BAYZF - AstraZeneca gets FDA priority review for new dosing regimen of tremelimumab/Imfinzi in liver cancer

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

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AstraZeneca gets FDA priority review for new dosing regimen of tremelimumab/Imfinzi in liver cancer