AstraZeneca and MSD's Lynparza (olaparib) has been approved in the EU for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
Lynparza is indicated as monotherapy for the maintenance treatment of adults 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 first-line chemotherapy regimen.
The approval was based on data from the Phase III POLO trial, published in The New England Journal of Medicine, in which 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 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 Kindler, co-principal investigator of the POLO trial and Professor of Medicine, University of Chicago Medicine.
“Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”
“Lynparza is now the only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic cancer,” added Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories.
“We look forward to making this targeted treatment option available for patients across the EU as quickly as possible.”
Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, such as mutations in BRCA1 and/or BRCA2.
The drug has already racked up a number of regulatory approvals in various territories for ovarian, breast, prostate and pancreatic cancers.