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US FDA panel backs AstraZeneca's pancreatic cancer drug Lynparza in 7-5 vote


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US FDA panel backs AstraZeneca's pancreatic cancer drug Lynparza in 7-5 vote

A panel of outside advisers to the U.S. Food and Drug Administration voted 7 to 5 in favor of approving AstraZeneca PLC's cancer drug, Lynparza, for a type of pancreatic cancer that has spread to other parts of the body.

Lynparza is a PARP inhibitor, meaning it prevents the PARP protein in cancer cells from repairing damaged DNA, thus causing the cancer cells to die. The drug is already approved for other BRCA-mutated cancer types, including ovarian cancer and breast cancer.

During a Dec. 17 meeting, the majority of the Oncologic Drugs Advisory Committee voted that Lynparza, co-developed with Merck & Co. Inc. and also known as olaparib, provided more benefit than risk to patients.

Lynparza is intended as a stand-alone maintenance treatment for patients with BRCA-mutated pancreatic cancer that has spread, called metastatic, but that has not progressed following first-line platinum-based chemotherapy.

In clinical trials, Lynparza halted the progression of patients' disease for longer compared to participants given placebo.

According to AstraZeneca's Dec. 17 press release, pancreatic cancer, the 12th-most-commonly occurring cancer, has the lowest survival rate of the most common cancers. Only chemotherapy, surgery and radiotherapy are currently available to treat pancreatic cancer.

Lynparza is slated to receive an FDA decision in the fourth quarter of 2019. The FDA is not required to take the advisory committee's recommendation.