Bristol Myers: FDA accepts sBLA for liver cancer
(CercleFinance.com) - Bristol Myers Squibb announces that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo plus Yervoy as a potential first-line treatment for adults with unresectable hepatocellular carcinoma (HCC).
This acceptance is based on the results of the phase 3 CheckMate -9DW trial demonstrating improved survival with this combination, compared with the investigator's choice of lenvatinib or sorafenib in this patient population.
The results of this study were presented at the 2024 annual meeting of the American Society of Oncology (ASCO). The US health authority has set the Prescription Drug User Fee Act (PDUFA) cut-off date at 21 April 2025.
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This acceptance is based on the results of the phase 3 CheckMate -9DW trial demonstrating improved survival with this combination, compared with the investigator's choice of lenvatinib or sorafenib in this patient population.
The results of this study were presented at the 2024 annual meeting of the American Society of Oncology (ASCO). The US health authority has set the Prescription Drug User Fee Act (PDUFA) cut-off date at 21 April 2025.
Copyright (c) 2024 CercleFinance.com. All rights reserved.