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Re: DewDiligence post# 200718

Tuesday, 12/12/2017 10:50:05 AM

Tuesday, December 12, 2017 10:50:05 AM

Post# of 257441
ABBV/Roche—Venclexta+Rituxan bests Treanda+Rituxan in rrCLL phase-3 MURANO study:

https://www.prnewswire.com/news-releases/abbvie-announces-phase-3-study-of-venclexta-venclyxto-venetoclax-in-combination-with-rituxan-rituximab-meets-its-primary-endpoint-300569874.html

The primary endpoint was PFS, which had a hazard ratio of 0.17(!). The trial was stopped for efficacy at the interim analysis.

With these results, the FDA accelerated approval granted in Apr 2016, which was for rrCLL patients with 17p deletion (#msg-121830825), will presumably be converted into a full FDA approval for rrCLL generally.

In the EU, Venclexta goes under the brand name, Venclyxto (#msg-125790701).

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