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CHMP recommends approval of Lynparza for metastatic adenocarcinoma of the pancreas.- AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lynparza (olaparib), from AstraZeneca. The CHMP adopted a new indication in adenocarcinoma of the pancreas.
The EMA recommends that Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.