VENCLYXTO® offers patients with CLL a chance to
BREAK FREE with longer progression-free survival1*†
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
NOW APPROVED in 1L CLL: VENCLYXTO + obinutuzumab
In 2L+ CLL:
VENCLYXTO + rituximab
*Reduced risk of progression or death vs O+Clb (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]). Median follow‑up of 28 months. Median PFS not reached in either arm.
†Reduced risk of progression or death vs BR (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]). Median follow‑up of 23.8 months. Median PFS not reached with VEN+R vs 17 months (15.5–21.6) with BR.
VENCLYXTO-based regimens have an established and manageable safety profile in CLL clinical trials1
- The most frequently reported serious adverse reactions (≥2%) in patients receiving VENCLYXTO in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS
- The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving VENCLYXTO in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhea, and upper respiratory tract infection
*Only the highest frequency observed in the trials is reported (based on studies CLL14, MURANO, M13-982, M14-032, and M12-175).
Grade 3 or 4 adverse events in the CLL14 VEN+O and O+Clb treatment arms2
Note to affiliate: See optional website content below for additional content based on the global CVA: ALL-VNNCCLL-2000028 that is not included in the SmPC. Use of this safety analysis should be evaluated by affiliate Med/Reg review based on local regulations and policy.
*Toxic effects in the two treatment groups were similar in severity, with significant differences detected only in the percentage of patients with metabolism and nutrition disorders and gastrointestinal disorders, including diarrhea.
†Nine patients received obinutuzumab only.
‡Adverse events are reported according to Medical Dictionary for Regulatory Activities superclass and preferred terms and National Cancer Institute Common Terminology Criteria for Adverse Events grade.
§Category includes tumor lysis syndrome and changes in electrolyte levels, each occurring in less than 3% of patients in each group. The two-sided P value was 0.02 for the between-group difference.
llThe two-sided P value was 0.01 for the between-group difference.
¶The two-sided P value was 0.03 for the between-group difference.
#Category includes hypertension and hypotension, each occurring in less than 3% of patients in each group.
**Category includes asthenia, pyrexia, fatigue, and chest pain, each occurring in less than 3% of patients in each group.
††Category includes different types of rash, each occurring in less than 3% of patients in each group.
Grade 3 or 4 adverse events in the MURANO VEN+R and BR treatment arms3
- The duration of treatment was longer in the VEN+R arm than in the BR arm
Note to affiliate: See optional website content below for additional content based on the global CVA: ALL-VNNCCLL-2000028 that is not included in the SmPC. Use of this safety analysis should be evaluated by affiliate Med/Reg review based on local regulations and policy.
*7 patients in the BR arm who did not receive treatment were not included in the safety analysis.
†2 serious adverse events of pneumonia that resulted in death occurred in patients who had both disease progression and confirmed Richter’s transformation (ie, conversion into an aggressive lymphoma, typically diffuse large B-cell lymphoma).
CLL=chronic lymphocytic leukemia; 1L=first line; 2L+=second line + later lines of therapy; O+Clb=obinutuzumab + chlorambucil; HR=hazard ratio; CI=confidence interval; PFS=progression-free survival; BR=bendamustine + rituximab; VEN+R=VENCLYXTO + rituximab; TLS=tumor lysis syndrome; MedDRA=Medical Dictionary for Regulatory Activities; VEN+O=VENCLYXTO + obinutuzumab.
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References: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.> 2. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. 3. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107‑1120.
GR-VNCCLL-200048 -JAN2021