NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) today recommended approval of olaparib (AstraZeneca/Merck's Lynparza) for the maintenance treatment of adult patients with germline BRCA1/2 mutations with metastatic pancreatic cancer who are responding to first-line platinum chemotherapy.
CHMP based its decision on the results of the Phase III POLO trial which showed that patients on olaparib had a median progression-free survival of 7.4 months compared to 3.8 months on placebo. The safety and tolerability of the drug was consistent with results seen in prior trials.
The US Food and Drug Administration approved this indication in December 2019, also based on the results of the POLO trial. The agency also approved Myriad Genetics' BRACAnalysis CDx to identify patients with such mutations who might benefit from treatment.