FDA accepts priority review application for AstraZeneca's tremelimumab

dl astrazeneca az pharma pharmaceuticals research and development laboratory ftse 100 — AstraZenecaSharecast graphic / Josh White

Drugmaker AstraZeneca said on Monday that an application for priority review of its tremelimumab asset had been accepted by the US Food and Drug Administration.

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AstraZeneca stated the FDA will have a regulatory decision in the fourth quarter. If successful, tremelimumab will be used for the treatment of patients with unresectable hepatocellular carcinoma,

The FTSE 100-listed firm added that a supplemental application had also been submitted for its Imfinzi asset, with the novel dose and schedule of the combination being called the STRIDE regimen - single tremelimumab regular interval durvalumab.

Astra said its STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi, was the first dual immune checkpoint blockade regimen to improve overall survival in a Phase III trial in this setting.

Susan Galbraith, AZN's executive vice president of oncology research and development, said: "The 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.

"Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible."