AbbVie (ABBV) announced Wednesday that the U.S. Food and Drug Administration granted a Breakthrough Therapy Designation or BTD to venetoclax (VENCLEXTA) in combination with azacitidine in Higher Risk Myelodysplastic Syndrome or MDS.
The BTD is granted for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk MDS based on revised International Prognostic Scoring System or IPSS-R. This marks the sixth BTD granted to venetoclax.
FDA’s BTD is intended to expedite the development and review of medications to treat a serious medical condition. It is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.
MDS are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein.
The company noted that the designation is supported by data from the Phase 1b M15-531 study. Venetoclax is also being investigated in combination with azacitidine for the treatment of MDS in the Phase Ib M15-522 study in patients with relapsed or refractory disease, and the Phase 3 randomized VERONA study in patients with newly diagnosed higher-risk MDS.
VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
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