FDA Grants Priority Review for AstraZeneca’s Imfinzi for Those With Biliary Tract Cancer


First phase 3 trial in this setting shows improved overall survival rates with an immunotherapy added to chemotherapy over the standard-of-care chemotherapy alone, company says.

The FDA has accepted and granted a supplemental biologics license application (sBLA) for durvalumab (Imfinzi; AstraZeneca) in combination with standard-of-care chemotherapy for priority review for individuals with locally advanced or metastatic biliary tract cancer (BTC).1

“[Individuals] with advanced BTC have faced poor outcomes and limited treatment options for too long, and [the] news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said in a statement. “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 durvalumab plus chemotherapy.”1

BTC is a group of aggressive and rare cancers that occur in the bile ducts and gallbladder, and approximately 23,000 individuals in the United States are diagnosed with BTC each year, according to the statement.

Typically, these individuals have a poor prognosis, with approximately 5% to 15% of individuals with BTC surviving 5 years.1

The FDA grants priority review to application for medicines that would offer significant improvements over available options by demonstrating efficacy or safety improvements, enhancing patient compliance, or preventing serious conditions, , if the medication were approved.1

The Prescription Drug User Fee Act date is during the third quarter of 2022, which is the FDA action date for its regulatory decision.1

The sBLA was based on results from an interim analysis of the TOPAZ-1 phase 3 trial presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.1

In the analysis, individuals treated with durvalumab in combination with standard-of-care chemotherapy experienced a 20% reduction in the risk of death versus chemotherapy alone.2

Additionally, the median overall survival was 12.8 months versus 11.5 for chemotherapy with an estimated 25% of individuals still alive at 2 years compared with 10% for chemotherapy alone.2

The findings also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy. The median progression-free survival was 7.2 months for the combination compared with 5.7 months for chemotherapy alone.2

Furthermore, individuals treated with durvalumab plus chemotherapy achieved an objective response rate of 26.7% compared with 18.7% chemotherapy alone.2

Durvalumab plus chemotherapy did not increase the discontinuation rate as the result of adverse events (AE) compared with chemotherapy alone. Grade 3 or 4 treatment-related AEs were experienced by 62.7% of individuals treated with the combination and by 64.9% of those treated with chemotherapy alone.2

The discontinuation of the treatment because of AEs occurred in 8.9% of individuals treated with the combination and 11.4% of those receiving just chemotherapy.2

In December 2020, durvalumab was granted orphan drug designation in the United States for the treatment of BTC.1


1. Imfinzi plus chemotherapy granted priority review in the US for patients with locally advanced or metastatic biliary tract cancer based on TOPAZ-1 phase III trial. AstraZeneca. News release. May 4, 2022. Accessed May 4, 2022. https://www.astrazeneca-us.com/media/press-releases/2022/imfinzi-plus-chemotherapy-granted-priority-review-in-the-us-for-patients-with-locally-advanced-or-metastatic-biliary-tract-cancer-based-on-topaz-1-phase-iii-trial-05042022.html

2. Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer. AstraZeneca. News release. January 18, 2022. Accessed May 4, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-plus-chemotherapy-reduced-risk-of-death-by-20-in-1st-line-advanced-biliary-tract-cancer.html

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