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AstraZeneca: Lynparza Gets EU Approval For BRCA-mutated Metastatic Pancreatic Cancer

AstraZeneca (AZN.L,AZN) and Merck & Co., Inc. (MRK) announced Wednesday that Lynparza (olaparib) has been approved in the European Union or EU for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers. Around 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.

Lynparza, jointly developed and commercialised by AstraZeneca and Merck, 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 1st-line chemotherapy regimen.

The EU approval for the drug was based on results from the Phase III POLO trial. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

The POLO trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. The safety and tolerability profile of Lynparza in the trial was consistent with previous trials.

Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer.

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