Clovis Oncology Soars to New 1-Year High

Clovis Oncology surged more than 15% intraday, touching its highest level since November 2015, after the U.S. Food and Drug Administration granted Monday an accelerated approval for Rubraca, which is marketed by the company to treat women with a certain type of ovarian cancer.

Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation — deleterious BRCA — as identified by an FDA-approved companion diagnostic test.

The National Cancer Institute estimates that 22,280 women will be diagnosed with ovarian cancer in 2016 and an estimated 14,240 will die of this disease. Approximately 15% to 20% of patients with ovarian cancer have a BRCA gene mutation.

The safety and efficacy of Rubraca were studied in two, single-arm clinical trials involving 106 participants with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens.