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AstraZeneca’s Blockbuster Cancer Drug Granted Priority Review for Rare Cancers


The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.

The FDA has granted priority review for AstraZeneca’s supplemental biologics license application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, for locally advanced or metastatic biliary tract cancer (BTC).

Imfinzi, a human monoclonal antibody, is already cleared to treat several other cancers, including unresectable, Stage 3 non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer, and advanced bladder cancer, AstraZeneca said in a news release.

Imfinzi sales rose 18% in 2021 to $2.4 billion. Since the first approval in May 2017, more than 100,000 patients have been treated with the drug.

The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.

BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder, and about 23,000 people in the United States are diagnosed with the cancers annually. Patients have a poor prognosis, with about 5% to 15% of patients with BTC surviving five years, AstraZeneca said

Imfinzi’s 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 (ASCO GI) Symposium, which showed Imfinzi plus chemotherapy (gemcitabine plus cisplatin) reduced the risk of death by 20% versus chemotherapy alone.

About 25% of patients treated with Imfinzi plus chemotherapy were alive at two years compared with 10% treated with chemotherapy alone. There was also a statistically significant 25% reduction in the risk of disease progression or death with Imfinzi plus chemotherapy.

Susan Galbraith

Susan Galbraith

The Imfinzi combination was generally well tolerated and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone, according to AstraZeneca.

“People with advanced biliary tract cancer 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 R&D at AstraZeneca, said in a press release.

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