Research & Development
Genentech submits supplemental New Drug Application for Venclexta to US FDA
16 July 2018 -

Genentech, a subsidiary of Roche, has submitted a supplemental New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Venclexta, in combination with either a hypomethylating agent or low dose cytarabine, it was reported on Friday.

The product is intended for the treatment of acute myeloid leukemia (AML) in earlier untreated patients who are ineligible for intensive chemotherapy.

The submission is based on the results of two Phase Ib/II studies that assessed the product in combination with azacitidine or decitabine (M14-358 study) or LDAC (M14-387 study) in this patient population. The product is being developed by AbbVie and Genentech. It is jointly commercialised by the companies in the United States and commercialised by AbbVie outside the United States.

Data recently presented from the Phase Ib M14-358 study showed Venclexta in combination with azacitidine or decitabine resulted in a complete remission rate (with or without full recovery of normal blood cell count; CR/CRi) of 73% in patients treated with Venclexta at a dose of 400mg.