AstraZeneca and MSD receive US approval for Lynparza for indication of advanced pancreatic cancer
AstraZeneca and MSD have confirmed that Lynparza (olaparib) has been approved for an indication of advanced pancreatic cancer in the US.
It follows encouraging results in the phase III POLO trial.
The drug was approved for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.
The trial showed patients lived without disease progression or death an average of 7.4 months when using Lynparza, compared to. 3.8 months on placebo.
Dave Fredrickson, executive vice president, oncology business unit, at AstraZeneca, 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.”
Julie Fleshman, president and CEO of the 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.”