Clovis Oncology won a faster-than-expected approval for its ovarian cancer drug Rubraca, gaining the FDA's approval two months ahead of the agency's anticipated action date.
Shares of Clovis closed at $40.48 on Dec. 19, up $3.28, or 8.8%, after the approval.
The drug belongs to a class of medicines known as poly ADP-ribose polymerase, or PARP, inhibitors, which work by blocking the action of an enzyme that plays a role in cancer growth. Rubraca is the second PARP inhibitor approved in the U.S. to treat ovarian cancer patients and the only one indicated to treat those who have been treated with two or more chemotherapies and whose cancer has particular genetic mutations, Clovis said in a Dec. 19 statement.
Rubraca is likely to compete with AstraZeneca PLC's Lynparza, also a PARP inhibitor, although Lynparza is indicated for a different group of ovarian cancer patients: those whose cancer has been treated with three or more prior lines of chemotherapy in addition to having certain genetic mutations. Clovis has priced Rubraca at $13,740 per month, higher than the $12,000 charged for Lynparza.
The approval of Rubraca is significant for Clovis after its experimental non-small cell lung cancer drug rociletinib was rejected by the FDA. Clovis in May said it was ending development of the drug.
After cutting its losses with rociletinib and trimming its staff, Clovis turned its full attention to Rubraca, which the FDA in April 2015 had deemed a breakthrough therapy — a designation aimed at speeding the regulatory process of drugs intended to treat serious and life-threatening conditions.
The company's application for Rubraca also was granted priority review status this past August, with the FDA setting Feb. 23, 2017, as the date to complete its evaluation.
The FDA for the past few years has been approving cancer drugs sooner than expected. Many of those go-aheads have come toward the end of the year, like in the case of Rubraca, boosting the annual approval numbers. But Clovis' drug is only the 21st new medicine approved in 2016 by the FDA's Center for Drug Evaluation and Research, which had cleared more than double that amount for novel products a year earlier.
Because Rubraca was cleared through the FDA's accelerated approval program, Clovis is required to complete a large confirmatory study to verify the drug's efficacy observed in two clinical trials. The drug's continued marketing is contingent on those confirmatory results.
Clovis said it plans to complete two confirmatory studies, one of which already has been fully enrolled.
The FDA also approved a companion diagnostic test for Rubraca from Foundation Medicine, known as FoundationFocus CDxBRCA, which is intended to help identify the most appropriate patients for the medicine.