Venclexta bounces back with FDA CLL nod in Gazyva combo

16 May 2019

The Roche (ROG: SIX) and AbbVie (NYSE: ABBV) partnered asset Venclexta (venetoclax) has won US approval in combination with Gazyva (obinutuzumab) as a first-line, chemo-free option in chronic lymphocytic leukemia (CLL).

This approval marks the fifth under a Breakthrough Therapy designation for Venclexta, which, along with participation in the US Food and Drug Administration’s Real-Time Oncology Review pilot program, led to approval in two months following submission of the complete application.

Venclexta has been a much-hyped medicine that selectively binds and inhibits the B-cell lymphoma-2 protein, and analysts have predicted that its peak sales could reach $2 billion, though trial deaths led to studies of the drug in multiple myeloma being halted in March.

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