AstraZeneca and MSD's Lynparza (olaparib) has been recommended for marketing authorisation in the EU for the first-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
The drug won the favour of the European Medicines Agency's human medicines committee on the back of its performance in the Phase III POLO trial, data from which were published in The New England Journal of Medicine.
The trial showed 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.
“Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU,” commented José Baselga, executive vice president, Oncology R&D, at AZ.
The CHMP recommendation covers maintenance treatment with Lynparza for 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.
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.