Double dose of EC approvals for AstraZeneca

21 December 2022

UK pharma major AstraZeneca (LSE: AZN) today announced two approvals from the European Commission for expanded indications for its blockbuster cancer drugs, one for Imfinzi (durvalumab) and the other for Lynparza (olaparib).

Imfinzi, which generated $737 million in third-quarter 2022 sales, has been approved in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

The approval was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence, and on the updated results presented at the European Society for Medical Oncology Congress 2022. The approval follows the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in November 2022.

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