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AstraZeneca, Merck get FDA approval for pancreatic cancer drug

Daniella Genovese

A new treatment for some patients with advanced pancreatic cancer that could double a patient's life expectancy was recently approved by the Food and Drug Administration.

British drug major AstraZeneca and Merck & Co. Inc. announced Monday the drug, olaparib, also known under its brand name as Lynparza, can be used to treat those with pancreatic cancer who have certain mutations of genes that help suppress tumors.

“Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades," said Dave Fredrickson, AstraZeneca's Oncology Business unit's executive vice president. "Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.”

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The drug was approved by the FDA as a treatment for adults with metastatic pancreatic cancer whose disease hasn’t worsened after 16 weeks of chemotherapy. Metastasis or metastatic cancer spread into different areas of the body.

Results from a trial published in The New England Journal of Medicine indicated that the drug reduced the risk of progression or death by 47 percent in patients whose disease hasn't worsened after 16 weeks of chemotherapy.

"The expanded approval of Lynparza represents a significant milestone for patients and supports the value of germline BRCA testing in patients with this disease," Roy Baynes, senior vice president and chief medical officer of Merck Research Labs, said referring to the types of genetic mutations.

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The disease has a "high unmet medical need" for treatment options, which AstraZeneca said. The deadly disease is the 12th most commonly occurring cancer in men and the 11th most commonly occurring cancer in women worldwide, according to the American Institute for Cancer Research.

Last year, there were approximately 460,000 cases diagnosed worldwide.

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In July 2017, the companies partnered to co-develop and co-commercialize Lynparza.

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