European green light for Lynparza in germline BRCA-mutated metastatic pancreatic cancer
pharmafile | July 8, 2020 | News story | Research and Development, Sales and Marketing | AstraZeneca, Cancer, Europe, MSD, lynparza
The European Commission has awarded approval to AstraZeneca and MSD’s Lynparza (olaparib) for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, with the drug becoming the only PARP inhibitor approved in Europe to treat the disease.
The ruling, which follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), specifically relates to gBRCAm patients with metastatic adenocarcinoma of the pancreas who have not seen disease progression following a minimum of 16 weeks of platinum treatment within a first line chemotherapy regimen.
Phase 3 data submitted in support of the decision showed that Lynparza showed strong progression-free survival benefit in this indication, almost doubling patient survival with disease progression to a median of 7.4 months compared to 3.8 months with placebo.
“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,” explained Dave Fredrickson, Executive Vice President, Oncology Business Unit at AstraZeneca. “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. This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalised treatment options for patients in the EU.”
Lynparza was already approved in the US in gBRCAm for the first line maintenance of their disease. Regulatory reviews are currently ongoing in other regions of the world.
Matt Fellows
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