NEW YORK – AstraZeneca and Merck said on Wednesday that the European Commission has approved the PARP inhibitor olaparib (Lynparza) as maintenance treatment for patients with germline BRCA-mutations who have metastatic pancreatic cancer.
The approval, which will make olaparib accessible across the European Union for patients whose cancer has not progressed after a minimum of 16 weeks on platinum-based chemotherapy, follows the positive recommendation issued last month by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
The CHMP recommendation and subsequent approval are based on the results of the Phase III POLO trial, which demonstrated a median progression-free survival of 7.4 months for patients treated with olaparib compared to 3.8 months on placebo. The safety and tolerability of the drug was consistent with the results of previous olaparib trials.
The EU approval also follows in the wake of the US Food and Drug Administration's approval for the same olaparib indication, which the agency granted in December 2019 alongside the approval of Myriad Genetics' BRACAnalysis CDx to identify patients with BRCA1 or BRCA2 mutations who might benefit from the drug.
"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," Heidi Kindler of the University of Chicago, who co-led the POLO trial, said in a statement. "Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer."