16 July 2018 - - South San Francisco, California-based biotechnology company Genentech, a member of the Roche Group (SIX: RO) (OTCQX: RHHBY), has submitted a supplemental new drug application (sNDA) to the US FDA for Venclexta (venetoclax), in combination with a hypomethylating agent or in combination with low dose cytarabine, for treatment of people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy, the company said.
The submission is based on the results of two phase Ib/II studies that evaluated Venclexta in combination with azacitidine or decitabine or with LDAC in this patient population.
Data from the phase Ib M14-358 study showed Venclexta in combination with azacitidine or decitabine resulted in a complete response/complete remission with incomplete hematologic recovery (CR/CRi) of 73% in patients treated with Venclexta at a dose of 400 mg.
The observed median overall survival (OS) across all Venclexta dose groups in the study was 17.5 months.
Results from the phase Ib/II M14-387 study of Venclexta in combination with LDAC showed a CR/CRi rate of 62% in patients treated with Venclexta at a dose of 600 mg. The observed median OS was 11.4 months.
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in apoptosis.
Overexpression of the BCL-2 protein in AML has been associated with resistance to certain therapies.
It is believed that blocking BCL-2 may restore the signaling system that tells cells, including cancer cells, to self-destruct.
Genentech discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.