AstraZeneca, Merck's Lynparza gets US FDA approval to treat pancreatic cancer

AstraZeneca and MSD Inc, announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen. 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 (ODAC) on 17 December for Lynparza in this indication, and was based on results from the pivotal phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.

Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where 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.

Dave Fredrickson, executive vice president, Oncology Business Unit, said, “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. Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer.”

Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories, said, “Lynparza embodies MSD’s and AstraZeneca’s commitment to advance the treatment of challenging types of cancer, including metastatic pancreatic cancer. The expanded approval of Lynparza represents a significant milestone for patients and supports the value of germline BRCA testing in patients with this disease.”

Hedy L. Kindler, co-principal investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine, said, “Today’s approval of olaparib based on the POLO results gives clinicians an important 1st-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer.”

Julie Fleshman, president and CEO, Pancreatic Cancer Action Network, said, “Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease. Today’s approval of Lynparza provides an exciting new treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”

The Pancreatic Cancer Action Network (PanCAN) is a US-based organisation that supports and advocates on behalf of the patients, caregivers and communities affected by pancreatic cancer.

Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=120258&sid=2

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