Good news is spreading for those that are battling pancreatic cancer as the U.S. Food and Drug Administration(FDA) has cleared the ovarian cancer drug known as Lynparza to treat advanced pancreatic cancer. AstraZeneca and Merck, the companies that developed it, announced recently.
“The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee (ODAC) on Dec 17 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,” according to the official press release.
The FDA approved Lynparza’s use as a maintenance treatment for those with so-called BRCA gene mutations whose cancer had spread beyond the pancreas and whose tumors did not grow after at least 16 weeks of chemotherapy.
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.
“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,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit.
“Metastatic pancreatic cancer patients have been waiting a long time for new therapy options for their devastating disease,” added Julie Fleshman, president, and CEO of Pancreatic Cancer Action Network.
Whether a patient meets criteria is determined by an FDA test according to reports.
Pancreatic cancer is known to be particularly deadly because it often goes undetected until it’s in advanced stages. The American Cancer Society estimates that nearly 46,000 Americans will die of the disease this year.