Tremelimumab Accepted Under Priority Review in the US

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Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

AstraZeneca’s biologics license application (BLA) for tremelimumab has been accepted for Priority Review in the United States for the treatment of patients with unresectable hepatocellular carcinoma (HCC) in combination with Imfinzi. A supplemental BLA has also been submitted for Imfinzi.

This novel dose and combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), which refers to a single priming dose of the anti-CTLA4 antibody added to Imfinzi. Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.

According to AstraZeneca, HCC is the most common type of liver cancer and is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Approximately 26,000 people in the US suffer from advanced, unresectable HCC each year. There is a critical unmet need for patients with HCC who face limited treatment options.


“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,” said Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, in a press release. “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.”

Source: AstraZeneca