FDA Grants Imfinzi-Chemo Combo Priority Review for Advanced Biliary Tract Cancer Treatment

The Food and Drug Administration (FDA) accepted a priority review for a supplemental biologics license application for Imfinzi (durvalumab) in combination with standard-of-care chemotherapy for the treatment of patients with locally advanced or metastatic biliary tract cancer, a group of rare cancers of the bile ducts and gallbladder.

A priority review is granted by the FDA in instances where if approved, a therapy would offer a massive improvement over what is already available.

“People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said in a press release. “We are working closely with the FDA to bring the first immunotherapy-based option to patients with this devastating cancer and potentially set a new standard of care with Imfinzi plus chemotherapy.”

The decision to grant the priority review was based on findings from an interim analysis of the phase 3 TOPAZ-1 clinical trial. Treatment with Imfinzi plus standard-of-care chemotherapy was associated with a 20% reduction in the risk of death compared with chemotherapy alone. Moreover, approximately 25% of patients who received the combination were alive at two years compared with 10% of those treated with only chemotherapy.

The use of the combination also elicited a 25% reduction in the risk of disease progression or death in patients.

As part of the review, the FDA plans to make its decision on whether to approve Imfinzi plus chemotherapy for this patient population between July and September 2022.

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