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FDA grants regular approval to Venclexta

June 8, 2018 9:11 PM UTC

FDA granted regular approval to Venclexta venetoclax alone or in combination with Rituxan rituximab to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in patients with or without the 17p deletion who have received one or more prior therapies. The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and AbbVie Inc. (NYSE:ABBV) are co-developing the drug. FDA had granted Venclexta accelerated approval to treat CLL in 2016.

The full approval is based on data from the Phase III MURANO trial, which showed that Venclexta plus Rituxan met the primary endpoint of improving investigator-assessed progression-free survival (PFS) versus Treanda bendamustine plus Rituxan...