Clovis lands early FDA OK for rucaparib
- Clovis Oncology has gained accelerated approval of its PARP inhibitor as monotherapy for advanced and pretreated ovarian cancer. Rubraca (rucaparib) got the ok from the Food and Drug Administration on Dec. 19, well ahead of its expected user fee goal date of Feb. 23.
- Full approval will depend on confirmatory studies — the ARIEL3 maintenance study is ongoing, and the ARIEL4 treatment study is now fully enrolled.
- The company said its will launch "as quickly as possible" and told investors during a conference call on Monday that Rubraca will cost $6,870 for a 15-day supply of either the 200mg or 300mg dosage strengths.
Clovis Oncology has received an early holiday present as Rubraca (rucaparib) has snagged approval to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations.
Rubraca will be used alongside an FDA-approved companion diagnostic, Foundation Medicine's FoundationFocus CDxBRCA. The approval comes two months before the PDUFA date.Due to the nature of the accelerated approval, full approval is still pending and needs to be backed up with data from further clinical trials. The drug's label will carry warnings and precautions for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
The drug will go up against AstraZeneca's PARP inhibitor Lynparza (olaparib), which gained FDA approval for advanced ovarian cancer in 2014. The British pharma will now be in the position to defend its market share. Pfizer, Tesaro and AbbVie also have PARP inhibitors in the works that will heat up this market.
Rubraca is also in clinical trials in pancreatic cancer and in combination with atezolizumab in gynecologic cancers. Studies in prostate cancer and gastroesophageal cancers are also ongoing. Trials are planned in combination with Genentech's bevacizumab in ovarian cancer.
Earlier this year, Clovis' lung cancer program stumbled, when the FDA voted against recommending approval for rociletinib. The company withdrew its European MAA for the drug and cut staff by 35%. This was a financial blow for the company, which had looked for early income from the drug's rolling approval while it carried on clinical trials, and a blow to its valuation too.
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