Lynparza approved in the EU for pancreatic cancer
AstraZeneca and MSD Inc reveal that potential blockbuster drug Lynparza (olaparib) – developed from Cambridge UK Intellectual Property – has been approved in the European Union for patients with germline BRCA-mutated metastatic pancreatic cancer.
Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate among the most common cancers.1 Approximately 5-7 per cent of patients with metastatic pancreatic cancer have a germline BRCA mutation.
The approval by the EC was based on results from the Phase III POLO trial, which were published in The New England Journal of Medicine. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Dave Fredrickson, AstraZeneca’s executive vice-president, Oncology Business Unit, said: “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.
“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.”
The POLO trial demonstrated that Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. The safety and tolerability profile of Lynparza in the trial was consistent with previous trials.
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a 1st-line chemotherapy regimen.
Lynparza is approved in the US and several other countries as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the Phase III POLO trial, with ongoing regulatory reviews in other regions.
As Business Weekly has previously and exclusively reported, the technology arose from discoveries made by Professor Steve Jackson’s Cancer Research UK-funded team in Cambridge.