Clovis looks to expand label for PARP inhibitor
- Clovis Oncology hopes to expand the addressable market for its ovarian cancer drug Rubraca, announcing Monday the filing of an application for approval of the drug as a maintenance therapy following response to platinum-based chemotherapy.
- Rubraca, one of three so-called PARP inhibitors on the market, is currently OK'd for third-line use in patients who have BRCA-mutated ovarian cancer. Results from a study presented in June showed the drug to be effective in extending disease control in a broader group of patients.
- In the second quarter, Tesaro, Inc.'s rival Zejula (niraparib) stole a leading market share away from AstraZeneca plc and Merck & Co's Lynparza (olaparib), but Lynparza recently won a broad expansion of its label that could help it take the top spot in the class.
Clovis' Rubraca (rucparib) secured an accelerated approval from the Food and Drug Administration in December 2016, and has since earned just over $20 million in net product sales.
Still, the biotech will have a degree of catching up to do if it wants to keep pace with Lynparza and Zejula. Both drugs gained supplementary approval for maintenance treatment in ovarian cancer this year, expanding the reach of both.
As it stood at the end of the second quarter, Zejula had captured a majority share of monthly PARP inhibitor-treated ovarian cancer patients. Yet with Lynparza now approved in maintenance and Rubraca closing in on a broader label, that hierarchy could soon see some changes.
An expected 22,400 women in the U.S. are expected to be diagnosed with ovarian cancer during 2017. Many are diagnosed with advanced disease and more options have been needed to adequately treat patients.
As with any new class of cancer treatments, one worry has been about the cost of PARP inhibitors as their approved uses are broadened to a wider pool of patients. All three drugs carry a list price of more than $12,000 dollars a month before rebates and discounts.
The Institute of Clinical and Economic Review, in particular, has raised concern's about the drug's cost-effectiveness as a maintenance therapy for ovarian cancer.
Dan Ollendorf, ICER's chief scientific officer, acknowledged in a recent statement PARP inhibitors' potential to improve on current treatment options and patient outcomes. But a report from the research group highlighted the need for further evidence on which patients would benefit the most as patient pools expand.
"Current pricing of PARP inhibitors has the potential to align with clinical benefit in recurrent disease, but alignment will be more challenging for these drugs when used as maintenance therapies," ICER said in a statement on the report's release.
- Clovis Oncology Press release
- BioPharma Dive ESMO: Clovis seeking new indication on positive ARIEL3 data
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