ABBV LAWSUIT: The Law Offices of Vincent Wong Notify Investors of a Class Action Lawsuit Involving AbbVie Inc
During both meetings, AbbVie will present nine abstracts evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational subcutaneous bispecific antibody, including data from multiple arms of the ongoing phase 1b /2 EPCORE™ NHL-2 clinical trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of various types of B-cell non-Hodgkin lymphoma (NHL). Additionally, data will be presented from the Phase 2 REFINE study of investigational compound navitoclax + ruxolitinib in JAK inhibitor-treatment-naïve patients with myelofibrosis.
At this year’s ASCO annual meeting AbbVie will be presenting on its solid tumor research with data from telisotuzumab vedotin (Teliso-V) in non-small cell lung cancer.
During the EHA Congress, the five-year update from the CLL14 trial of a combined regimen of venetoclax + obinutuzumab versus obinutuzumab + chlorambucil comparing the efficacy and safety in participants with untreated chronic lymphocytic leukemia (CLL) will be presented.
Details about presentations are as follows:
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ASCO 2022 Abstracts |
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Abstract |
Presentation Details All Times in CT |
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Ibrutinib |
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Primary Results From the Double-Blind, |
Session: Hematologic Malignancies— Friday, June 3, 2022 1:00 – 4:00 p.m. CT Oral |
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Fixed-Duration (FD) Ibrutinib (I) Plus |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Phase 1/2 Study of Zilovertamab and Ibrutinib |
Session: Hematologic Malignancies— Saturday, June 4, 2022 3:00 – 4:30 p.m. CT Poster |
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Prognostic Testing and Treatment Patterns in |
Abstract Publication Only |
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Upper Gastrointestinal (GI) Morbidity, Peptic |
Abstract Publication Only |
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Characteristics and Clinical Outcomes |
Abstract Publication Only |
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Real-World Clinical Outcomes in Patients |
Abstract Publication Only |
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Venetoclax |
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Efficacy and Safety of Venetoclax |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Epcoritamab* |
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First-Line Treatment (Tx) With Subcutaneous |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Subcutaneous Epcoritamab With Rituximab + |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Subcutaneous Epcoritamab + R-DHAX/C in |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Epcoritamab (Epco) with Gemcitabine + |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Navitoclax |
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Navitoclax Plus Ruxolitinib in JAK inhibitor- |
Session: Hematologic Malignancies – 8:00 – 11:00 a.m. CT Poster Saturday, June 4, 2022 1:15 – 2:45 p.m. CT Poster Discussion |
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Lemzoparlimab |
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Lemzoparlimab (Lemzo) with Venetoclax |
Session: Hematologic Malignancies— Saturday, June 4, 2022 8:00 – 11:00 a.m. CT Poster |
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Teliso-V |
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Phase 1/1B study of Telisotuzumab Vedotin |
Session: Lung Cancer – Non-Small Cell Monday, June 6, 2022 8:00 – 11:00 a.m. CT Poster 1:15 – 2:45 p.m. CT Poster Discussion |
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Telisotuzumab Vedotin (Teliso-V) |
Session: Lung Cancer – Non-Small Cell Monday, June 6, 2022 8:00 – 11:00 a.m. CT Poster 1:15 – 2:45 p.m. CT Poster Discussion |
The ASCO 2022 Annual Meeting abstracts are available here .
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EHA 2022 Abstracts |
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Abstract |
Presentation Details All Times in CT |
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Ibrutinib |
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Immune Restoration and Synergistic Activity |
Session: CLL: Translational Research Saturday, June 11, 2022 9:30 – 10:45 a.m. CT Oral |
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Primary Results From the Phase 3 Shine Study |
Session: Indolent and Mantle Cell Lymphoma Saturday, June 11, 2022 4:30 – 5:45 a.m. CT Oral |
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Absence of BTK, BCL2, and PLCG2 Mutations |
Session: Chronic lymphocytic leukemia and 9:30-10:45 a.m. CT Poster |
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Fixed-Duration (FD) Ibrutinib + Venetoclax for |
Friday, June 10, 2022 9:30 – 10:45 a.m. CT Poster |
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Cross-Trial Analysis of Fixed-Duration Ibrutinib |
Session: Chronic lymphocytic leukemia and |
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Venetoclax*** |
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Venetoclax-Obinutuzumab for Previously |
Session: CLL: Clinical Sunday, June 12, 2022 4:30 – 5:45 a.m. CT Oral |
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VIALE-M: A Randomized, Double-Blind, 2-Arm, |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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VIALE-T: A Randomized, Open-Label, Phase 3 |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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The Impact of Post-Remission Granulocyte |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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Transfusion Independence Among Newly |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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Clinical Outcomes in Patients With |
Session: Myelodysplastic syndromes – Clinical 9:30 – 10:45 a.m. CT Poster |
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Venetoclax in Patients With Chronic |
Session: CLL: Clinical Friday, June 12, 2022 4:30 – 5:45 a.m. CT Oral |
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Treatment Sequences and Outcomes of |
Session: Chronic lymphocytic leukemia and 9:30 – 10:45 a.m. CT Poster |
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Healthcare Resource Utilization and Costs Of |
Abstract Publication Only |
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Transcriptomic Characterization of MRD Treated With Fixed-Duration Venetoclax- |
Session: CLL: Translational Saturday, June 11, 2022 9:30 – 10:45 a.m. CT Oral |
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Fixed-Duration (FD) Ibrutinib (I) Plus |
Friday, June 10, 2022 9:30 – 10:45 a.m. CT Poster |
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PedAL/EuPAL International Collaboration to |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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Cross-Trial Analysis of Fixed-Duration Ibrutinib |
Session: Chronic lymphocytic leukemia and |
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Safety and Effectiveness of Venetoclax |
Session: Chronic lymphocytic leukemia and 9:30 – 10:45 a.m. CT Poster |
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Effectiveness and Safety of Venetoclax in |
Session: Chronic lymphocytic leukemia and 9:30 – 10:45 a.m. CT Poster |
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Real-Life Efficacy and Safety of Venetoclax |
Session: Chronic lymphocytic leukemia and 9:30 – 10:45 a.m. CT Poster |
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Venetoclax in Combination With Obinutuzumab |
Session: Quality of life, palliative care, ethics 9:30 – 10:45 a.m. CT Poster |
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Lemzoparlimab** |
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Lemzoparlimab (Lemzo) With Venetoclax (Ven) |
Session: Acute myeloid leukemia – Clinical 9:30 – 10:45 a.m. CT Poster |
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Epcoritamab* |
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Assessing Safety, Tolerability, and Efficacy of |
Session: Aggressive Non-Hodgkin lymphoma |
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Subcutaneous (SC) Epcoritamab + R-CHOP in |
Friday, June 10, 2022 9:30 – 10:45 a.m. CT Poster |
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Subcutaneous (SC) Epcoritamab With |
Friday, June 10, 2022 4:30 – 5:45 p.m. CT Poster |
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Subcutaneous (SC) Epcoritamab + R-DHAX/C |
Friday, June 10, 2022 9:30 – 10:45 a.m. CT Poster |
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Epcoritamab With Gemcitabine + Oxaliplatin |
Friday, June 10, 2022 9:30 – 10:45 a.m. CT Poster |
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Navitoclax |
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Navitoclax Monotherapy in Patients (Pts) With |
Session: Myeloproliferative neoplasms – Clinical 9:30 – 10:45 a.m. CT Poster |
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Navitoclax plus ruxolitinib in JAK Inhibitor-naïve |
Session: Treatments and complications in MPN 4:30 – 5:45 a.m. CT Oral |
The EHA 2022 Congress abstracts are available here .
* Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.
**Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.
***Use of venetoclax in myelodysplastic syndromes (MDS) is not approved and its safety and efficacy have not been evaluated by regulatory authorities.
About Ibrutinib (IMBRUVICA ® )
IMBRUVICA ® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech, Inc. IMBRUVICA ® blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, to multiply and spread. 1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. 3
IMBRUVICA ® is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 ongoing or completed Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA ® .
IMBRUVICA ® was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include adults with CLL/small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p) and adults with Waldenström’s macroglobulinemia (WM), as well as adult patients with previously treated mantle cell lymphoma (MCL)*, adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy*, as well as adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. 4
*Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
Since 2019, the National Comprehensive Cancer Network ® (NCCN ® ), recommends ibrutinib (IMBRUVICA ® ) as a preferred regimen for first-line treatment of CLL/SLL, with Category 1 status for previously untreated patients without del17p. Additionally, IMBRUVICA ® is a preferred treatment regimen for previously untreated patients with del17p. Since January 2020, the NCCN Guidelines recommend IMBRUVICA ® as a category 2A preferred regimen for the treatment of relapsed/refractory MCL. Since September 2020, the NCCN Guidelines recommend IMBRUVICA ® with or without rituximab as a Category 1 preferred regimen for both untreated and previously treated WM patients.
For more information, visit www.IMBRUVICA.com .
*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
Important Side Effect Information 5
Before taking IMBRUVICA ® , tell your healthcare provider about all of your medical conditions, including if you:
- have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA ® for any planned medical, surgical, or dental procedure.
- have bleeding problems.
- have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
- have an infection.
- have liver problems.
- are pregnant or plan to become pregnant. IMBRUVICA ® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA ® . Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA ® .
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA ® and for 1 month after the last dose.
- Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA ® and for 1 month after the last dose.
- are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA ® and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA ® with certain other medicines may affect how IMBRUVICA ® works and can cause side effects.
How should I take IMBRUVICA ® ?
- Take IMBRUVICA ® exactly as your healthcare provider tells you to take it.
- Take IMBRUVICA ® 1 time a day.
- Swallow IMBRUVICA ® capsules or tablets whole with a glass of water.
- Do not open, break or chew IMBRUVICA ® capsules.
- Do not cut, crush or chew IMBRUVICA ® tablets.
- Take IMBRUVICA ® at about the same time each day.
- If you miss a dose of IMBRUVICA ® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA ® at your regular time on the next day. Do not take extra doses of IMBRUVICA ® to make up for a missed dose.
- If you take too much IMBRUVICA ® call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking IMBRUVICA ® ?
- You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA ® . These products may increase the amount of IMBRUVICA ® in your blood.
What are the possible side effects of IMBRUVICA ® ?
IMBRUVICA ® may cause serious side effects, including:
- Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA ® , and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
- Infections can happen during treatment with IMBRUVICA ® . These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA ® .
- Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA ® , but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
- Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA ® , especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA ® dose.
- High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA ® . Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
- Second primary cancers. New cancers have happened during treatment with IMBRUVICA ® , including cancers of the skin or other organs.
- Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
The most common side effects of IMBRUVICA ® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:
- diarrhea
- tiredness
- muscle and bone pain
- rash
- bruising
The most common side effects of IMBRUVICA ® in adults with cGVHD include:
- tiredness
- bruising
- diarrhea
- mouth sores (stomatitis)
- muscle spasms
- nausea
- pneumonia
Diarrhea is a common side effect in people who take IMBRUVICA ® . Drink plenty of fluids during treatment with IMBRUVICA ® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.
These are not all the possible side effects of IMBRUVICA ® . Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of IMBRUVICA ®
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA ® for a condition for which it was not prescribed. Do not give IMBRUVICA ® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA ® that is written for health professionals.
Please click here for full Prescribing Information. 5
About VENCLEXTA®/VENCLYXTO® (venetoclax) 6
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S.
Important Safety Information 7
What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.
Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.
- Tell your healthcare provider about all the medicines you take , including prescription and over-the counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
- Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions,
including if you:
- have kidney or liver problems.
- have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
- have a history of high uric acid levels in your blood or gout.
- are scheduled to receive a vaccine. You should not receive a “live vaccine” before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
- are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
- are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.
What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
- Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
- Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.
The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.
The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.
VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.
You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance .
The full U.S. prescribing information, including Medication Guide, for VENCLEXTA ® can be found here .
Indications and Important Venclyxto (venetoclax) EU Safety Information 8
Indications
VENCLYXTO in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
VENCLYXTO monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
Contraindications
Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as Venclyxto efficacy may be reduced.
Special Warnings & Precautions for Use
Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).
Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase. During postmarketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax.
Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period.
In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.
For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.
Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment, including antimicrobials and dose interruption or reduction as appropriate.
Live vaccines should not be administered during treatment or thereafter until B-cell recovery.
Drug Interactions
In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.
In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.
In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.
Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.
CYP3A4 inducers may decrease Venclyxto plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations.
Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.
Adverse Reactions
CLL
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
The most frequently occurring serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
Discontinuations due to adverse reactions occurred in 16% of patients in both combination studies (CLL14 and MURANO). In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in the CLL14 study, in 15% of patients treated with the combination of venetoclax and rituximab in the Murano study, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia.
AML
The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.
The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.
Discontinuations due to adverse reactions occurred in 24 % of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.
Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65 % of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia. The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.
Special Populations
Patients with reduced renal function (CrCl
For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.
Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.
This is not a complete summary of all safety information. See Venclyxto (venetoclax) SmPC at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells. 9 Epcoritamab was developed with selective, silencing mutations that may limit, systemic non-specific activity. 10 CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia. 11 ,12 Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies’ broad oncology collaboration.
About Lemzoparlimab
Lemzoparlimab is investigational and being developed through a comprehensive clinical development plan for hematologic malignancies and solid tumor in collaboration with AbbVie and I-Mab.
About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway. 13 Navitoclax is not approved by any regulatory authority. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.
AbbVie is currently recruiting for two Phase 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with ruxolitinib for the treatment of myelofibrosis that will enroll more than 500 patients. The company anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.
About Telisotuzumab Vedotin
Teliso-V is an investigational antibody-drug conjugate (ADC) targeting c-Met, a receptor tyrosine kinase that is overexpressed in tumors including NSCLC. Teliso-V is not approved by any regulatory authority and its safety and efficacy are under evaluation.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology .
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Genetics Home Reference. Isolated growth hormone deficiency. http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency . Accessed November 2020 .
2 Turetsky, et al. Single cell imaging of Bruton’s Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014)
3 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
4 IMBRUVICA U.S. Prescribing Information, April 2020 .
5 IMBRUVICA U.S. Prescribing Information, April 2020 .
6 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
7 ISI verified against ISI listed on venclexta.com 24Oct2021
8 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.
9 “Diffuse Large B-Cell Lymphoma.” Lymphoma Research Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/ ; date accessed: 11 February 2022 .
10 van der Horst, H.J., de Jonge, A.V., Hiemstra, I.H. et al. Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. Blood Cancer J. 11, 38 (2021). https://doi.org/10.1038/s41408-021-00430-6
11 Rafiq, Sarwish, et al. “Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties.” J. Immunol. ( Baltimore , Md. 1950), U.S. National Library of Medicine, 15 Mar. 2013, www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/ .
12 Singh, Vijay, et al. “Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response.” J Cancer Sci Ther., U.S. National Library of Medicine, Nov. 2015, www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/ .
13 Tsujimoto Y. (1998). Role of Bcl-2 family proteins in apoptosis: apoptosomes or mitochondria?. Genes to cells: devoted to molecular & cellular mechanisms, 3(11), 697–707. https://doi.org/10.1046/j.1365-2443.1998.00223.x
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