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The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.
The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union, it was revealed by AstraZeneca and MSD in a July 8, 2020 press release.
Approval for the therapy was based on the results from the Phase III POLO trial, which demonstrated that Lynparza nearly doubled the amount of time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death. The commission’s decision follows the recommendation for approval made by the Committee for Medicinal Products for Human Ise of the European Medicines Agency.
“Today’s approval opens the door to a new era of biomarker-led care for patients with metastatic pancreatic cancer in the EU, which has the highest incidence of any region globally,” said Hedy L. Kindler, co-principal investigator of the POLO trial and professor of medicine, University of Chicago Medicine, in the press release. “Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
“Patients with metastatic pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades. In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after 1st-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer,” added Dave Fredrickson, executive vice-president, Oncology Business Unit, AstraZeneca, in the press release. “This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalized treatment options for patients in the EU.”
Roy Baynes, senior vice-president and head of global clinical development, chief medical officer, MSD Research Laboratories, said, in the press release, “MSD and AstraZeneca are committed to advancing research into the treatment of patients with challenging types of cancer, including those with metastatic pancreatic cancer. Lynparza is now the only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic cancer. We look forward to making this targeted treatment option available for patients across the EU as quickly as possible.”