- Clovis Oncology Inc. has notched a label expansion for its only marketed product, Rubraca, lifting the company's stock about 5% in Friday afternoon trading.
- Rubraca first gained approval from the Food and Drug Administration in late 2016 as a third-line treatment for a subset of women with advanced ovarian cancer. Now, it is also OK'd as a maintenance therapy for adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who demonstrated complete or partial response to platinum-based chemotherapy.
- The fresh approval helps close the gap between Rubraca and Lynparza, a competitor drug from AstraZeneca plc. Both are part of a promising class of cancer therapies called PARP inhibitors, yet AstraZeneca's offering came to market a couple years earlier and boasts a broader label.
The FDA has signed off on just three PARP inhibitors so far: Lynparza (olaparib), Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib). All three hold indications in ovarian cancer, yet the Clovis drug has had the hardest time carving out market share.
That's largely because of its label.
Up until Friday, Rubraca was only for women who underwent two or more chemotherapies and whose tumors have a specific gene mutation, dubbed deleterious BRCA.
Conversely, Lynparza has been able to function as a sort of second-line treatment since its August 2017 approval as a maintenance therapy for recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers. Zejula also holds a maintenance treatment indication for those cancers, but isn't encumbered by any BRCA mutation or biomarker testing requirements.
Such discrepancies can be seen in the drugs' revenue. AstraZeneca reported Lynparza sales of about $300 million last year, while sales for Zejula hit $109 million. Revenue from Rubraca clocked in at a more modest $56 million.
Clovis has been working to close that gap, and focused much of its efforts on building out the label for its PARP inhibitor. The Colorado-based biotech is investigating Rubraca in several other cancers, including urothelial carcinoma and breast cancer, as well as in combination with checkpoint inhibitors like Bristol-Myers Squibb Co.'s Opdivo (nivolumab).
In the near term, analysts expect Rubraca will benefit from the maintenance therapy indication.
"We think US approval of Rubraca in the broad 2nd line maintenance indication ... is an important growth driver for the product which has a competitive profile according to physicians we surveyed in November," Leerink analyst Michael Schmidt wrote in a February note.