On May 30, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported it will present more than 40 data updates across its oncology portfolio during the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31-June 4, in Chicago, and the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress on June 13-16, in Amsterdam (Press release, AbbVie, MAY 30, 2019, View Source [SID1234536684]). The data presentations will span the company’s investigational and approved oncology portfolio medicines in more than 15 different blood and solid tumor cancers.
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For the first time, researchers will also present data from the Phase 3 CLL14 study evaluating venetoclax (VENCLEXTA/VENCLYXTO) plus obinutuzumab versus obinutuzumab plus chlorambucil at ASCO (Free ASCO Whitepaper) (abstract #7502). Results from the trial supported the recent FDA approval of this VENCLEXTA chemotherapy-free combination for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Researchers will also present new, multi-year, long-term data on the use of single-agent ibrutinib (IMBRUVICA) in CLL/SLL at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) in 2019. Six years of follow-up data evaluating previously treated patients on ibrutinib therapy from the Phase 3 RESONATETM trial (PCYC-1112) will be presented as a poster discussion at ASCO (Free ASCO Whitepaper) (abstract #7510), and more than five years of follow-up for previously untreated patients on ibrutinib therapy from the Phase 3 RESONATE-2TM trial (PCYC-1115/1116) will be presented in an oral session at EHA (Free EHA Whitepaper) (abstract #S107). The RESONATETM trial’s long-term follow-up data presentation was also selected to be featured at the Best of ASCO (Free ASCO Whitepaper) 2019 Meetings, which highlight cutting-edge science and reflect the leading research and strategies in oncology. Following updates earlier this year, the National Comprehensive Cancer Network (NCCN) now recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and the only Category 1 single-agent regimen for patients without 17p deletion.1
"The data AbbVie is presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) provide a glimpse into the progress we are making collaboratively advancing a diverse pipeline across a broad range of hematologic malignancies and solid tumors," said Neil Gallagher, M.D., Ph.D., vice president, head of global oncology development, AbbVie. "We continue to make progress with first-in-class medicines like ibrutinib and venetoclax that are approved and are being further investigated as potential treatments for several different forms of hematologic malignancies. AbbVie is also advancing a diverse oncology portfolio of investigational drugs with the potential to address unmet needs in other difficult-to-treat cancers."
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
VENCLEXTA is a first-in-class BCL-2 inhibitor being developed by AbbVie and Roche. VENCLEXTA 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.
To learn more about our work in oncology, visit View Source
Presentations include:
Abstract
Presentation Timing
ASCO Annual Meeting
Ibrutinib
Final Analysis From RESONATE: 6-Year Follow-up
in Patients (Pts) With Previously Treated Chronic
Lymphocytic Leukemia or Small Lymphocytic
Lymphoma (CLL/SLL) on Ibrutinib; Barr et al.;
Abstract #7510
Monday, June 3
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 11:30 a.m. – 1:00 p.m. CT
Patient-Reported Outcomes (PROs) With
Ibrutinib-Rituximab in Waldenström
Macroglobulinemia (WM): Results From
iNNOVATE; Tedeschi et al.; Abstract #8018
Monday, June 3
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 1:15 p.m. – 2:45 p.m. CT
Interim Analysis of Ibrutinib Plus Paclitaxel for
Patients With Advanced Urothelial Carcinoma
Previously Treated With Platinum-Based
Chemotherapy; Castellano et al.; Abstract #4522
Monday, June 3
Poster Session: 1:15 p.m. – 4:15 p.m. CT
Venetoclax
Effect of Fixed-Duration Venetoclax Plus
Obinutuzumab (VenG) on Progression-Free
Survival (PFS), and Rates and Duration of Minimal
Residual Disease Negativity (MRD-) in Previously
Untreated Patients (pts) with Chronic
Lymphocytic Leukemia (CLL) and Comorbidities;
Fischer K, et al.; Abstract #7502
Tuesday, June 4
Oral Session: 9:45 a.m. – 12:45 p.m. CT
Oral Presentation: 10:09 a.m. – 10:21 a.m. CT
Outcomes of Patients with t(11;14) Multiple
Myeloma: An International Myeloma Working
Group (IMWG) Multicenter Study; Durie BG, et al.;
Abstract #8015
Monday, June 3
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 1:15 p.m. – 2:45 p.m. CT
Randomized Phase 2 Trial of Venetoclax +
Fulvestrant Versus Fulvestrant in Estrogen
Receptor+, HER2- Locally Advanced or Metastatic
Breast Cancer Following Recurrence or
Progression During or After a CDK4/6 Inhibitor:
VERONICA; Lindeman GJ, et al.; Abstract
#TPS1108
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Veliparib
Veliparib in Combination with
Chemoradiotherapy (CRT) of
Carboplatin/Paclitaxel (C/P) Plus Radiation in
Patients with Stage III Non-Small Cell Lung Cancer
(NSCLC); Kozono DE, et al.; Abstract #8510
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 11:15 a.m. – 12:45 p.m. CT
Mivebresib
Results from the First-in-Human Study of
Mivebresib (ABBV-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients with Relapsed/Refractory Acute Myeloid
Leukemia; Odenike O, et al.; Abstract #7030
Monday, June 3
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Cell Free DNA in Uveal Melanoma: Results from
the First in Human Trial of Mivebresib (ABBV-
075); Patel SP, et al.; Online Publication
Online Publication
Depatux-M
Phase 1/2 Study of Depatuxizumab Mafodotin
(ABT-414) Monotherapy or Combination with
Temozolomide in Japanese Patients with/without
EGFR-Amplified Recurrent Glioblastoma; Narita Y,
et al.; Abstract #2065
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Rova-T
Phase 1 Study on Preliminary Efficacy of
Rovalpituzumab Tesirine in Japanese Patients
with Advanced, Recurrent Small Cell Lung Cancer;
Akamatsu H, et al.; Abstract #8557
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Ph1/2 Study of Rova-T in Combination with
Nivolumab (Nivo) ± Ipilimumab (Ipi) for Patients
(Pts) with 2L+ Extensive-Stage (ED) SCLC;
Malhotra J, et al.; Abstract #8516
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 11:15 a.m. – 12:45 p.m. CT
Predictors Associated with Development of
Pleural and Pericardial Effusions in Patients with
Small Cell Lung Cancer Treated with Third-Line
Therapy; Jiang R, et al.; Online Publication
Online Publication
Teslio-V
Results of the Phase 1b Study of ABBV-399
(Telisotuzumab Vedotin; Teliso-V) in Combination
with Erlotinib in Patients with c-Met+ Non-Small Cell
Lung Cancer by EGFR Mutation Status;
Camidge DR, et al.; Abstract #3011
Saturday, June 1
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 3:00 p.m. – 4:30 p.m. CT
c-Met Expression and Response to Telisotuzumab
Vedotin (Teliso-V) in Patients with Non-Small Cell
Lung Cancer; Heist RS, et al.; Abstract #9023
Sunday, June 2
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 4:30 p.m. – 6:00 p.m. CT
Peripheral Neuropathy Among Patients with
NSCLC Undergoing Chemotherapy; Tyczynski JE,
et al.; Online Publication
Online Publication
ABBV-085
First-in-Human Phase 1 Study of ABBV-085, an
Antibody-Drug Conjugate (ADC) Targeting
LRRC15, in Sarcomas and Other Advanced Solid
Tumors; Demetri GD, et al.; Abstract #3004
Monday, June 3
Oral Session: 8:00 a.m. – 11:00 a.m. CT
Oral Presentation: 9:12 a.m. – 9:24 a.m. CT
ABBV-621
Phase 1, First-In-Human Study of TRAIL Receptor
Agonist Fusion Protein ABBV-621; Ratain MJ, et
al.; Abstract #3013
Saturday, June 1
Poster Session: 8:00 a.m. – 11:00 a.m. CT
Poster Discussion: 3:00 p.m. – 4:30 p.m. CT
ABBV-181
Safety and Efficacy of Anti-PD-1 Inhibitor ABBV-
181 in Lung and Head and Neck Carcinoma;
Italiano A, et al.; Online Publication
Online Publication
EHA Annual Congress
Ibrutinib
Five Year Follow-Up of Patients Receiving
Ibrutinib for First-Line Treatment of Chronic
Lymphocytic Leukemia; Tedeschi A, et al.;
Abstract #S107
Monday, June 14
Oral Session: 11:30 a.m. – 12:45 p.m. CEST
Oral Presentation: 12:00 p.m. – 12:15 p.m. CEST
Patient-Reported Outcomes from the
iNNOVATETM Study: Results of Ibrutinib-Rituximab
in Waldenström Macroglobulinemia (WM);
Tedeschi A, et al.; Abstract #PF614
Monday, June 14
Poster Display: 5:30 p.m. – 7:00 p.m. CEST
Prognostic Testing and Treatment Approaches
Based on Real-World Clinical Experience from an
Interim Analysis of the INFORMCLL Registry of
Patients with Chronic Lymphocytic Leukemia;
Mato AR, et al.; Abstract #PF383
Monday, June 14
Poster Display: 5:30 p.m. – 7:00 p.m. CEST
Venetoclax
A Phase 1b/2 Clinical Study of Targeted IDH1
Inhibition with Ivosidenib in Combination with the
BCL-2 Inhibitor Venetoclax for Patients with IDH1-
mutated (mIDH1) Myeloid Malignancies; DiNardo
CD, et al.; Abstract #PF291
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Factors Impacting Treatment Selection in
Treatment-Naïve Patients with CLL: A Multicenter
Study; Rhodes J, et al.; Abstract #PF381
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Venetoclax for Chronic Lymphocytic Leukemia: A
Retrospective Chart Review of Safety and Efficacy
From Preapproval Cohort Programs in the
European Union; Schuh, et al.; Abstract #PS1165
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Venetoclax Alone or in Combination with
Rituximab for Japanese Patients with
Relapsed/Refractory Chronic Lymphocytic
Leukemia; Yamamoto K, et al.; Abstract #PB1890
Online Publication
Efficacy and Safety of Ibrutinib in
Relapsed/Refractory Chronic Lymphocytic
Leukemia in Patients Previously Treated with
Venetoclax in the MURANO Study; Greil R, et al.;
Abstract #PS1161
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Impact of Major Genomic Alterations on Outcome
of Relapsed/Refractory (R/R) Chronic Lymphocytic
Leukemia (CLL) Patients (Pts) Treated With
Venetoclax Plus Rituximab (Venr) in the Phase 3
MURANO Study; Wu J, et al.; Abstract #PS1123
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Genetic Markers and Outcome in the CLL14 Trial
of the GCLLSG Comparing Front Line
Obinutuzumab Plus Chlorambucil or Venetoclax in
Patients with Comorbidity; Tausch E, et al.;
Abstract #S105
Friday, June 14
Oral Presentation: 11:30 a.m. – 11:45 a.m. CEST
Updated Safety and Efficacy From a Phase 2
Study of Venetoclax Plus Carfilzomib and
Dexamethasone in Patients with
Relapsed/Refractory Multiple Myeloma; Costa LJ,
et al.; Abstract #PS1375
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Improved Outcome in Patients With BCL2-Positive
Diffuse Large B-Cell Lymphoma Treated With
Venetoclax Plus R-Chop: Results From the Phase 2
CAVALLI Study; Morschhauser F, et al.; Abstract
#PF294
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Mivebresib
Results From the First-In-Human Study of
Mivebresib (Abbv-075), a Pan-Inhibitor of
Bromodomain and Extra Terminal Proteins, in
Patients With Relapsed/Refractory Acute Myeloid
Leukemia; Borthakur G, et al.; Abstract #PF254
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Navitoclax
Combination BCL-2 Inhibitor Therapy With
Venetoclax (Ven) and Navitoclax (Nav) in Patients
with Relapsed/Refractory (R/R) Acute
Lymphoblastic Leukemia (ALL) and Lymphoblastic
Lymphoma (LL); Pullarkat V, et al.; Abstract
#PS940
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Additional Research
Outcomes Of Patients With t(11;14) Multiple
Myeloma: An International Myeloma Working
Group Multicenter Study; Kumar S, et al.; Abstract
#PF564
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Longitudinal Treatment Patterns and Patient
Characteristics Among Individuals Diagnosed
With CLL in Israel; Weil C, et al.; Abstract #PS1166
Saturday, June 15
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
Patient Characteristics, Transplant Frequency,
and Treatments in Multiple Myeloma; Karve S, et
al.; Abstract #PF724
Friday, June 14
Poster Session: 5:30 p.m. – 7:00 p.m. CEST
About VENCLEXTA/VENCLYXTO (venetoclax)
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. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.2
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 and other cancers.
VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need. Venetoclax is not approved by any regulatory authority, in any country for the treatment of multiple myeloma.
Uses and Important VENCLEXTA (venetoclax) U.S. Safety Information2
Use
VENCLEXTA is a prescription medicine used:
to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacytidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.
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.
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 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.
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.
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 low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts; infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.
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. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit View Source or call 1-800-FDA-1088.
If you cannot afford your medication, contact www.pparx.org for assistance.
Please see full Prescribing Information, including Medication Guide.
Important VENCLYXTO (venetoclax) EU Safety Information3
VENCLYXTO (venetoclax) Indication
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia(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 chemo immunotherapy and a B-cell receptor pathway inhibitor.
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 tumor lysis syndrome (TLS). Concomitant use of preparations containing St. John’s wort as VENCLYXTO efficacy may be reduced.
Special Warnings & Precautions for Use
Tumor lysis syndrome (TLS), including fatal events, has occurred in patients with previously treated CLL with high tumor burden when treated with VENCLYXTO. VENCLYXTO poses a risk for TLS in the initial 5-week 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. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.
Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. Serious infections including events of sepsis with fatal outcome have been reported. Supportive measures including antimicrobials for any signs of infection should be considered.
Live vaccines should not be administered during treatment or thereafter until B-cell recovery.
Drug Interactions
CYP3A inhibitors may increase VENCLYXTO plasma concentrations. 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, physicians should refer to the SmPC for dose adjustment recommendations. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations.
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
The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhea, nausea, anemia, fatigue, and upper respiratory tract infection.
The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with rituximab or as monotherapy were pneumonia, febrile neutropenia and TLS.
Discontinuation due to adverse reactions occurred in 16% of patients receiving venetoclax plus rituximab and 9% receiving venetoclax monotherapy. Dosage adjustments due to adverse reactions occurred in 15% of patients receiving venetoclax plus rituximab and 2% receiving venetoclax monotherapy. Dose interruptions occurred in 71% of patients treated with the combination of venetoclax and rituximab.
Specific Populations
Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. VENCLYXTO should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.
VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.