Rubraca Gets FDA Priority Review for New Use

December 12, 2017

The FDA recently decided to accelerate priority review of Rubraca (rucaparib; Clovis) to determine the drugs’ efficacy as a maintenance therapy for ovarian cancer.

Rubraca is a twice-daily, oral, monotherapy for the treatment of patients with a BRCA mutation (germline and/or somatic) as a third-line option.

“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 announcing the priority review. “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.”

Based on early data from the ARIEL3 trial of Rubraca, the FDA decided to accelerate its decision for approving Rubraca from the normal 10 months to 6 months. The FDA has stated it will make a decision on Rubraca before April 6, 2018.

If Rubraca is approved as a maintenance therapy, it will be indicated for the treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in chemotherapy. The approval will also remove the BCRA mutation requirement for use of the drug, saving the cost of expensive genetic testing and removing a potential barrier to treatment.

In this space, Rubraca will compete with other PARP inhibitors including Lynparza (olaparib; AstraZeneca/Merck) and Zejula (niraparib; Tesaro). Reports indicate that all three drugs have demonstrated similar efficacy results; however, Rubraca currently boasts fewer adverse events on its label. If Rubraca clears the FDA approval without adding additional warnings to its label, it could have a significant impact in ovarian cancer treatment.

This news comes after the FDA announced it would accelerate review of oncology medications based on early trial data in order to increase competition and reduce drug costs.


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