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AstraZeneca: Lynparza Recommended For Marketing Authorisation In EU

AstraZeneca Plc (AZN.L,AZN) and Merck & Co., Inc.(MRK) announced Monday that the European Medicines Agency or EMA recommended Lynparza (olaparib) for marketing authorisation in the European Union. The recommendation is for the 1st-line maintenance treatment of patients with germline BRCA-mutated or gBRCAm metastatic pancreatic cancer.

EMA's Committee for Medicinal Products for Human Use or CHMP based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.

The 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.

In the trial, the drug's safety and tolerability profile was consistent with previous trials.

The CHMP recommendation is for maintenance treatment with Lynparza for 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.

Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the Phase III POLO trial, with ongoing regulatory reviews in the EU and other jurisdictions.

In the U.S., the drug was recently approved for patients with homologous recombination repair or HRR gene-mutated metastatic castration-resistant prostate cancer.

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