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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US

The drug combination offers biliary tract cancer patients a new treatment option


AstraZeneca’s (AZ) has announced that its treatment, Imfinzi (durvalumab), in combination with chemotherapy, has been accepted and given a Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC).

An interim analysis of the TOPAZ-1 phase 3 trial – which was presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium – formed the basis for AZ’s supplemental Biologics License Application (sBLA), submitted to the US Food and Drug Administration (FDA).

The FDA allows Priority Review applications to be granted for medicines that, with approval, have the potential to offer significant improvements over available treatment options by showing improvements in safety or effectiveness, by preventing serious conditions, or by enhancing patient compliance.

Data taken from the TOPAZ-1 phase 3 trial demonstrated Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% compared to the use of chemotherapy alone.

Survival rates were approximately 25% for patients treated with Imfinzi plus chemotherapy by year two compared 10% of patients treated with chemotherapy alone.

There was a significant 25% reduction in the risk of disease progression or death when using Imfinzi plus chemotherapy as a treatment, while the data also showed that the Imfinzi combination was generally well tolerated.

BTC is a group of rare and aggressive gastrointestinal cancers that are created in the cells of the bile ducts, gallbladder or ampulla of Vater. Early-stage BTC often presents without obvious symptoms, leading to most new cases of BTC being diagnosed at an advanced stage. This can leave patients with limited treatment options and a poor prognosis.

It is estimated that 23,000 people in the US are diagnosed with BTC each year, and these same patients will typically have a poor prognosis, with around 5% to 15% of patients with BTC surviving five years.

Susan Galbraith, executive vice president, oncology R&D, AZ, said: “people with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long”.

She added that the teams at AZ “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”.

Article by
Fleur Jeffries

6th May 2022

From: Regulatory



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