- Clovis Oncology said it expects a decision from the Food and Drug Administration on approval of its ovarian cancer drug rucaparib by February 23, 2017, announcing on Tuesday that the agency has accepted its application for accelerated approval.
- With a target action date for rucaparib in hand, Clovis hopes to recover from a major setback earlier this year when the oncology company decided to shut down clinical testing of its lung cancer drug rociletinib and cut 35% of its staff.
- The slow-burn failure of rociletinib had caused Clovis stock to plummet from over $100 per share last fall to below $20 per share this year. Investors reacted positively to the news of the FDA's acceptance of rucaparib's application, lifting the stock by over 27% in Tuesday trading.
Clovis is pinning its hopes on rucaparib after the damaging failure of rociletinib dragged Clovis stock down from its lofty valuation and led to significant layoffs in May. Several days after shutting down clinical trials for rociletnib, the company also disclosed a government investigation into an update given on the drug's efficacy last November which lowered the tumor response rates originally reported.
Rucaparib, a PARP inhibitor, has been in development as a third-line treatment of ovarian cancer patients with BRCA-mutated tumors. Two studies across 106 patients showed treatment with the drug led to an objective response rate of 54% in a pooled analysis.
Clovis stock was lifted in June after Massachusetts-based Tesaro announced positive late-stage results for its ovarian cancer drug niraparib, also a PARP inhibitor. The strong data on niraparib raised expectations for the entire drug class, including rucaparib and another PARP inhibitor in development by the recently-acquired Medivation.
Tesaro plans to file for U.S. approval of niraparib sometime in the fourth quarter of this year.
Clovis is also testing rucaparib in combination with Roche's PD-L1 inhibitor Tecentriq for second-line treatment of ovarian cancer. A Phase 1b study is slated to begin in the first quarter of 2017.
Other studies examining rucaparib against metastatic castration-resistant prostate cancer are planned for later this year and early next year.
Clovis licensed rucaparib from Pfizer in 2011 and owes the big pharma mid-teen royalties as well as milestone payments should the PARP inhibitor get approved—these payments could reach $170 million.