Clovis Oncology to seek FDA approval for ovarian cancer drug as a maintenance therapy

Shares of Clovis Oncology Inc. soared 40.0% in premarket trading on Thursday after the company said its drug, Rubraca, improved survival when used as a maintenance treatment for women with ovarian cancer. The data comes from a double-blind, placebo-controlled, Phase 3 clinical trial that enrolled 538 women. Clovis said it plans to seek approval for Rubraca in the E.U. and the U.S. this year as first-line maintenance treatment for women with advanced ovarian cancer regardless of their biomarker status and who have already responded to chemotherapy. Rubraca is already approved as a third-line treatment in BRCA-mutated ovarian cancer. Clovis shares are down 39.1% this year, while the broader S&P 500 has declined 3.4%.

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