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FDA Approves Clovis Oncology's Ovarian Cancer Treatment

FDA Approves Clovis Oncology's Ovarian Cancer Treatment

Shares of Clovis Oncology Inc (NASDAQ: CLVS) soared higher by more than 15 percent Monday after the U.S. Food and Drug Administration granted an accelerated approval for the company's PARP inhibitor rucaparib for the treatment of women with advanced ovarian cancer which will now be branded under the name Rubraca.

The approval could come as a surprise to some investors as some among Wall Street doubted this outcome would occur.

Clovis' stock soared to the $42 level at around 11:10 a.m. ET and was halted on a circuit breaker. The code on the halt was then switched to news pending and hadn't resumed trading as of 11:51 a.m. ET.

The FDA confirmed in a press release that 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.

As noted by the Cancer Therapy Advisor, Rucaparib significantly prolonged the progression-free survival of patients with BRCA-mutant or BRCA wild-type and high loss of heterozygosity (LOH).

Specifically, treatment with Clovis' therapy reduced the risk of progression or death by 73 percent in the BRCA-mutant group and by 38% in the LOH high subgroup in a clinical trial.

"Today's approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient's genes," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and acting director of the FDA's Oncology Center of Excellence. "Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option."

In a sympathy move, Tesaro Inc (NASDAQ: TSRO) fell more than 2.5 percent and traded recently around $128.14.

Posted-In: Accelerated Approval Cancer Therapies Clovis OncologyNews Health Care FDA Movers General Best of Benzinga


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