VENCLYXTO® (venetoclax tablets)

Dosing Guide

VENCLYXTO SmPC/Country- specific labeling

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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.

Offer your patients the chance for a treatment-free period with durable remission

DEEP RESPONSE* AND LONGER PFS WITH FIXED TREATMENT DURATION¹

1L CLL: VEN+O Fixed treatment duration regimen of 1 year

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])

2L+ CLL: VEN+R Fixed treatment duration regimen of 2 years

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.

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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

ALL-VNCCLL-220060 May 2024

VENCLYXTO (venetoclax) PRESCRIBING INFORMATION/SmPC

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