AstraZeneca : Imfinzi Combination Approved In EU For Advanced Biliary Tract Cancer Treatment

British drug major AstraZeneca Plc.'s (AZN.L,AZN) Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine plus cisplatin).

The approval by the European Commission was based on the primary results from the TOPAZ-1 Phase III trial. The results showed Imfinzi combination reduced risk of the death by 24% compared to chemotherapy alone.

The approval follows the recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022.

Imfinzi plus chemotherapy is approved in the US and other countries for the treatment of adults with locally advanced or metastatic Biliary tract cancer. Regulatory applications are also currently under review in Japan and several other countries based on the TOPAZ-1 results.

Biliary tract cancer is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).

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