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FDA Approves AstraZeneca's Lynparza, Myriad Genetics' CDx for BRCA-Positive Pancreatic Cancer

NEW YORK – The US Food and Drug Administration expanded the indication for AstraZeneca and Merck's olaparib (Lynparza) as a maintenance treatment for certain metastatic pancreatic cancer patients identified with the help of a companion diagnostic, the two drugmakers announced on Monday.

According to the new drug approval, pancreatic cancer patients must have responded to a first-line platinum-based chemotherapy regimen and not progressed for at least four months. Additionally, patients must have germline mutations in BRCA1 and BRCA2 genes as identified by an FDA approved companion test. 

Along with olaparib's expanded approval, the FDA also approved Myriad Genetics' BRACAnalysis CDx to identify patients with such mutations who might benefit from treatment. Following the announcement of the approval, Myriad's stock price increased by around 2 percent to $27.30 in early morning trading on the Nasdaq.

Metastatic pancreatic cancer is an aggressive disease that has limited treatment options. "Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease," Pancreatic Cancer Action Network CEO Julie Fleshman said in a statement.

Earlier this month, the FDA's Oncologic Drugs Advisory Committee recommended the agency approve olaparib for this indication based on the results of the Phase III POLO trial. In that study, presented earlier this year at the American Society of Clinical Oncology's annual meeting, olaparib-treated patients had median progression-free survival of 7.4 months, compared to 3.8 months in the placebo arm. The data, which were also published in the New England Journal of Medicine, showed that olaparib reduced the risk of progression or death in pancreatic cancer patients by around 47 percent.

Dave Fredrickson, AstraZeneca's head of oncology business, said in a statement that Lynparza is the only targeted medicine approved by regulators for metastatic pancreatic cancer in a biomarker-selected population. Approximately 6 percent of pancreatic cancer patients have germline BRCA1 and BRCA2 mutations. 

AstraZeneca markets Lynparza in the US and Canada, while Merck markets the drug elsewhere.

The National Comprehensive Cancer Network recommends that all pancreatic cancer patients receive genetic testing to assess their inherited risk for cancer. Earlier this month, the group updated its guidelines for assessing genetic risk for breast, ovarian, and pancreatic cancer to include more information on the genes associated with pancreatic cancer and what screening or management approaches clinicians should take if individuals have pathogenic or likely pathogenic mutations in these genes.

Olaparib is already approved in the US for HER2-negative, metastatic breast cancer patients with germline BRCA 1/2 mutations who have received prior chemotherapy. For ovarian cancer patients, the drug is also approved for the maintenance treatment of platinum-sensitive patients with germline or somatic BRCA mutations; for platinum-sensitive recurrent ovarian cancer regardless of BRCA mutation status; and as a fourth-line treatment for patients with advanced disease and germline BRCA mutations.

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