CHMP recommends Lynparza for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient -positive advanced ovarian cancer. AstraZeneca + Merck Inc.

Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a biomarker subgroup analysis of the PAOLA-1 Phase III trial, which was published in The New England Journal of Medicine.The trial showed that Lynparza in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition of Lynparza improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. For patients with advanced ovarian cancer, the primary aim of 1st-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission.