Note to affiliates: This update to the venetoclax CLL AbbVie Pro site includes a homepage headline, updated CLL14 6-year and MURANO 7-year data sets, and other streamlined content updates. The CLL14 6-year and MURANO 7-year data have been updated based on the EHA 2023 abstracts. For countries that cannot use these data sets, please follow local regulations and MRLO guidance, and revert to CLL14 5-year and MURANO 5-year published data from the product label.
Primary analysis in ITT population for VEN+O vs O+Clb1:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.35; 95% CI: 0.23–0.53 [P<0.0001]).
| • | Median follow-up of 28 months |
Additional analyses:
6-year PFS estimate (INV-assessed)2‡: 53% vs 22% (HR=0.40; 95% CI: 0.31–0.52) after 5 years off treatment.
| • | Median PFS of 76.2 months with VEN+O vs 36.4 months with O+Clb |
INV-assessed complete remission (CR/CRi)1: 50% vs 23% (P<0.0001).
| • | ORR: 85% (95% CI: 79.2–89.2) vs 71% (95% CI: 64.8–77.2 [P=0.0007]) |
Primary analysis in ITT population for VEN+R vs BR:
INV-assessed PFS†: Reduced risk of progression or death (HR=0.17; 95% CI: 0.11–0.25 [P<0.0001]).
| • | Median follow-up of 23.8 months |
Additional analyses:
7-year PFS estimate (INV-assessed)3‡: 23% (95% CI: 16.1–29.9) vs NE after ~5 years off treatment.
| • | Median PFS of 54.7 months with VEN+R (95% CI: 52.3–59.9) vs 17.0 months with BR (95% CI: 15.5–21.7) |
INV-assessed complete remission (CR/CRi)1‡: 27% vs 8%.
| • | ORR: 93% (95% CI: 88.8–96.4) vs 68% (95% CI: 60.6–74.2) |
*See full dosing information for VEN+O and for VEN+R in the dosing and administration section.
†Primary endpoint.
‡Results are descriptive only.
1L=first line; CLL=chronic lymphocytic leukaemia; VEN+O=VENCLYXTO + obinutuzumab; ITT=intent to treat; O+Clb=obinutuzumab + chlorambucil; INV=investigator; PFS=progression-free survival; HR=hazard ratio; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete bone marrow recovery; ORR=overall response rate; 2L+=second line + later lines of therapy; VEN+R=VENCLYXTO + rituximab; BR=bendamustine + rituximab; NE=not evaluable.
SELECT ADDITIONAL SAFETY AND DRUG INTERACTIONS INFORMATION1
CONTRAINDICATIONS
| • | Hypersensitivity to the active substance or to any of the excipients |
| • | Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase |
| • | Concomitant use of preparations containing St. John’s wort |
RENAL IMPAIRMENT
| • | Safety in patients with renal impairment of CrCl <15 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 (CrCl ≥15 and <30 mL/min) only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS |
HEPATIC IMPAIRMENT
| • | A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment |
SELECT DRUG INTERACTIONS: CYP3A INHIBITORS AND INDUCERS
| • | Concomitant use of VENCLYXTO with strong CYP3A inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated |
| • | Concomitant use of VENCLYXTO with strong or moderate CYP3A inhibitors (eg, ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) increases VENCLYXTO exposure and may increase the risk for TLS at initiation and during the dose-titration phase and for other toxicities. Consider alternative treatments |
| • | Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with VENCLYXTO as they contain inhibitors of CYP3A |
*Avoid concomitant use of VENCLYXTO with moderate CYP3A inhibitors at initiation and during the dose-titration phase. Consider alternative medications or reduce the VENCLYXTO dose as described.
| • | Patients should be monitored closely for signs of toxicities and the dose may need to be further adjusted |
| • | Resume the VENCLYXTO dose that was used prior to initiating the CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor |
| • | Concomitant use of VENCLYXTO with strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampicin) or moderate CYP3A inducers (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided |
| • | Alternative treatments with less CYP3A induction or without CYP3A inhibition should be considered |
| • | Preparations containing St. John’s wort are contraindicated during treatment with VENCLYXTO, as efficacy may be reduced |
CYP3A=cytochrome P450 3A; CrCl=creatinine clearance; TLS=tumour lysis syndrome.
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. 2. AI-Sawaf O, Robrecht S, Zhang C, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study. HemaSphere. 2023;7(S3):1-3. 3. Kater A, Harrup R, Kipps TJ, et al. Final 7-year follow up and retreatment substudy analysis of MURANO: venetoclax-rituximab (VENR)-treated patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL). Abstract presented at the European Hematology Association Congress 2023; June 8-11, 2023; Frankfurt, Germany.
ALL-VNCCLL-220060 May 2024