The U.S. Food and Drug Administration (FDA) has granted Priority Review Status to Clovis Oncology’s application to expand its approval for Rubraca (rucaparib) to include recurrent ovarian cancer maintenance treatment. A decision is expected by April 6, 2018.
Clovis submitted the application, which specifies that the maintenance treatment should be used in women who are sensitive to platinum-based chemotherapy, in October 2017.
“We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release.
“We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make rucaparib available to these women in a more expeditious manner.”
The priority designation shortens the time the FDA requires to review an application from 10 months to six months, and is granted to drugs that provide a considerable improvement in the safety or effectiveness of a treatment for a serious condition.
The so-called supplemental New Drug Application was based on data from the Phase 3 ARIEL3 trial (NCT01968213), which included 564 women with high-grade ovarian, fallopian tube, or primary peritoneal cancer who had at least a partial response to platinum chemotherapy.
The data, which Clovis presented at the European Society for Medical Oncology (ESMO) 2017 Congress, showed that Rubraca prevented the cancer from reappearing for longer than a placebo. It also appeared to boost the response to earlier chemotherapy.
The trial data, published in the journal The Lancet, show that women with BRCA mutations benefited the most from the treatment. But Rubraca also improved progression-free survival in the other patients, allowing the trial to meet its primary objective.
Clovis plans to submit an application to use Rubraca for ovarian cancer maintenance treatment with the European Medicines Agency in early 2018. European regulators, however, are still reviewing the company’s initial application to use Rubraca in advanced ovarian cancer. Their decision on Rubraca’s potential approval for this indication is expected by the end of the year.
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