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# Genentech ‘Breakthrough’ for Myelodysplastic Drug
- URL: https://www.fdaweb.com/genentech-breakthrough-for-myelodysplastic-drug/
- Published: 2021-07-21T12:00:00.000Z
- Updated: 2026-09-14T17:07:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149758

FDA has granted Genentech a breakthrough therapy designation for Venclexta (venetoclax) in combination with azacitidine for treating adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS). The designation was granted based on interim results from the Phase Ib M15-531 study investigating Venclexta plus azacitidine in people with previously untreated, higher-risk MDS. Venclexta is currently approved in the U.S. in combination with azacitidine, decitabine or low-dose cytarabine for treating newly diagnosed acute myeloid leukemia in adults 75 years or older.