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News
Europe's drug advisory committee has recommended approval of senaparib (Sepalna) as a first-line maintenance treatment for advanced ovarian cancer. Based on the phase 3 FLAMES trial, senaparib cut the risk of disease progression or death by 57% compared to placebo. The recommendation now moves to the European Commission for final authorization.
Europe's drug advisory body, the Committee for Medicinal Products for Human Use (CHMP), has issued a positive opinion recommending marketing authorization for senaparib (Sepalna) as a first-line maintenance therapy for advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer. This recommendation is a major step toward full European Commission approval.
The decision is grounded in results from the phase 3 FLAMES trial, a randomized, multicenter study in patients with newly diagnosed stage III–IV high-grade ovarian cancer who responded to platinum-based chemotherapy. Senaparib — taken orally once daily — dramatically outperformed placebo, with median progression-free survival (PFS) not yet reached in the treatment arm versus just 13.6 months in the placebo group. Notably, the benefit held across both BRCA-mutated and BRCA-negative patient subgroups.
By the Numbers:
Why it matters: Ovarian cancer is often diagnosed at an advanced stage, making effective maintenance therapies critical. Senaparib's strong PFS benefit across BRCA subgroups could broaden treatment options for a wider patient population in Europe.
