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AstraZeneca: Lynparza Approved In US For Pancreatic Cancer - Quick Facts

British drug major AstraZeneca (AZN,AZN.L) and Merck & Co., Inc. (MRK) announced that the US Food and Drug Administration has approved Lynparza (olaparib) as a 1st-line maintenance treatment of germline BRCA-mutated or gBRCAm metastatic pancreatic cancer.

The drug is for adult patients with deleterious or suspected deleterious gBRCAm pancreatic cancer whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.

The company said patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee for Lynparza in this indication. The approval was based on results from the pivotal Phase III POLO trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival. In the trial, Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo.

The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.

Lynparza, jointly developed and commercialised by AstraZeneca and Merck, is approved for advanced ovarian cancer and metastatic breast cancer.

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