Quickie approval of Clovis’ PARP drug sends stock up

FDA
Clovis Oncology won FDA approval for PARP inhibitor rucaparib ahead of schedule

Clovis Oncology has won approval for rucaparib in a particular population of ovarian cancer patients. The accelerated FDA approval of the PARP inhibitor two months ahead of schedule sparked a 9% rise in Clovis’ share price and set the company up to start competing for market share with AstraZeneca’s Lynparza.

FDA signed off on the use of rucaparib—which will be sold as Rubraca—in ovarian cancer patients who have undergone two or more lines of chemotherapy and have deleterious germline or somatic BRCA mutations. The indication overlaps with that targeted by Lynparza, which is approved for use in patients with deleterious BRCA mutated ovarian cancer who have been through three or more lines of chemotherapy.

Clovis secured approval in the indication on the strength of data on the 106 patients who took part in two single-arm trials. Among these BRCA-mutated patients, Rubraca achieved an overall response rate of 54%. The complete or partial shrinkage of tumors lasted a median of 9.2 months. Those data proved compelling enough for FDA to approve Rubraca this week, well ahead of its PDUFA date of February 23.

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Clovis plans to sell Rubraca for just shy of $14,000 a month, putting its price in the same ballpark as AstraZeneca’s Lynparza. FDA made Lynparza the first approved PARP inhibitor two years ago. That gave AstraZeneca control of the PARP inhibitor space for a period. Rubraca is one of multiple drugs looking to make the sector a little more congested.

The next wave of PARP inhibitors differ in terms of patient populations and other aspects, though, something Tesaro was keen to drill home after the approval of Rubraca coincided with a slide in its stock price.

“There remains no approved therapy for patients with recurrent disease who achieve a response to platinum-based chemotherapy,” Tesaro CEO Lonnie Moulder said in an emailed statement. “An oral treatment that may reduce the risk of progression and lengthen the interval between rounds of intravenous chemotherapy could be very meaningful for patients, who often live with a fear of recurrence after completing a chemotherapy regimen.”

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