publication date: Nov. 30, 2018
Drugs & Targets
FDA grants Venclextra accelerated approval for newly-diagnosed AML
FDA has granted an accelerated approval to Venclexta (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine, for the treatment of people with newly-diagnosed acute myeloid leukemia, who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.
Venclexta is sponsored by Genentech, a member of the Roche Group.
This accelerated approval was based on results from the M14-358 study and the M14-387 study in people newly-diagnosed with AML including those who were ineligible for intensive induction chemotherapy.
In M14-358, the rate of complete remission was 37 percent (n=25/67) and the rate of complete remission with partial blood count recovery was 24 percent (n=16/67) for those who received Venclexta plus azacitidine.
For those who received Venclexta plus decitabine, the rate of CR was 54 percent (n=7/13) and the rate of CRh was 8 percent (n=1/13). M14-387 showed a CR rate of 21 percent (n=13/61) and a CRh rate of 21 percent (n=13/61) for those who received Venclexta in combination with LDAC.
Venclexta is being developed by AbbVie and Genentech. It is jointly commercialized by the companies in the U.S. and commercialized by AbbVie outside of the U.S.
The M14-358 study (NCT02203773) is an open-label, non-randomized, phase Ib dose escalation and expansion study evaluating the safety and efficacy of Venclexta in combination with hypomethylating agents, azacitidine or decitabine, in newly-diagnosed people with AML who were 60 years or older, or ineligible to receive intensive induction chemotherapy due to coexisting medical conditions.
Study endpoints included complete remission rates, overall survival and safety.
Continue reading FDA grants Venclextra accelerated approval for newly-diagnosed AML
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