Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer
Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.
The 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 POLO trial was consistent with previous trials.
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