British drug major AstraZeneca Plc. (AZN.L,AZN) announced Monday that the U.S. Food and Drug Administration has approved Imfinzi (durvalumab) as the first immunotherapy regimen for patients with advanced biliary tract cancer or BTC.
Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) has been approved for the treatment of adult patients with locally advanced or metastatic BTC.
The approval was based on the results from the TOPAZ-1 Phase III trial. In an interim analysis of TOPAZ-1, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. The company noted that Imfinzi plus chemotherapy was generally well tolerated and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.
The TOPAZ-1 Phase III trial results were presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers or ASCO GI Symposium. The results were also published in the New England Journal of Medicine Evidence.
In July 2022, Imfinzi plus chemotherapy was added to the NCCN Clinical Practice Guidelines in Oncology as a Category 1 preferred regimen as 1st-line therapy for locally advanced or metastatic BTC based on the data from TOPAZ-1.
The approval was granted after securing Priority Review and Orphan Drug Designation for Imfinzi in the US in this setting. Regulatory applications are also currently under review in Europe, Japan and several other countries based on the TOPAZ-1 results.
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