AstraZeneca Imfinzi combo for biliary tract cancer gets approval in EU
Roland Magnusson


The European Commission (EC) approved AstraZeneca's (NASDAQ:AZN) Imfinzi in combination with chemotherapies gemcitabine and cisplatin, as a firstâline treatment for adults with unresectable or metastatic biliary tract cancer (BTC).
The expanded approval of Imfinzi (durvalumab) combo by the EC was backed by data from a phase 3 trial called TOPAZ-1. The decision follows a recommendation for approval by a panel of the the European Medicines Agency (EMA) in November.

BTC is a group of rare and aggressive cancers which occur in the bile ducts (cholangiocarcinoma) and gallbladder.
"With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer," said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca.
The British pharma giant noted that Imfinzi plus chemotherapy is approved in the U.S. and certain other countries to treat adults with locally advanced or metastatic BTC.
Imfinzi is also approved in the U.S., EU, and certain other countries to treat certain types of lung and bladder cancers.