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.
GSK releases decade-long data on Shingrix efficacy
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients