Clovis Oncology says ovarian cancer drug rucaparib awarded breakthrough status by FDA

Associated Press

Shares of Clovis Oncology got a boost Monday after the company said it will get special incentives as it studies its ovarian cancer drug rucaparib.

The company said the Food and Drug Administration designated rucaparib as a "breakthrough treatment" for advanced ovarian cancer in some patients. The FDA's decision means Clovis will get extra meetings with the FDA and earlier communication with scientists as it studies the drug.

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Shares of Clovis Oncology Inc. advanced $3.91, or 5.7 percent, to $72.55 in after-hours trading.

The FDA's designation applies to rucaparib when it's used as a stand-alone treatment in women who have already received chemotherapy and who carry the BRCA gene mutation, which significantly increases the risk of breast and ovarian cancer.

The Boulder, Colorado-based company does not have any approved drugs. Its lung cancer drug rociletinib was deemed a breakthrough therapy in May, and Clovis plans to file for marketing approval in the next few months. The company intends to file for marketing approval of rucaparib in 2016.

Clovis Oncology stock slipped 88 cents to $68.64 on Monday. It has climbed 23 percent in 2015.