AstraZeneca gets FDA priority review for new dosing regimen of tremelimumab/Imfinzi in liver cancer
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The Food and Drug Administration (FDA) granted priority review to AstraZeneca's (NASDAQ:AZN) application for a single priming dose of tremelimumab added to Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma, a type of liver cancer.
The British drugmaker's had submitted a biologics license application (BLA) for the tremelimumab combo and novel dose and schedule is called STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
The FDA is expected to make a decision in Q4 2022. Under priority review the FDA's goal is to take action on an application within 6 months, compared to 10 months under standard review.
The company added that it also submitted a supplemental BLA (sBLA for Imfinzi in this indication.
The company said the BLA and sBLA are backed by final results from a phase 3 trial called HIMALAYA, which showed that patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib, sold as Nexavar by (OTCPK:BAYZF) (OTCPK:BAYRY). The company added that nearly one in three (31%) patients were still alive at three years, compared to one in five (20%) for sorafenib.
âThe HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to Imfinzi, highlighting the potential for this regimen to improve longer-term survival outcomes," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca (AZN).