Clovis Gets Positive CHMP Opinion For Ovarian Cancer Drug
Zacks Investment Research | Mar 25, 2018 09:40PM ET
Clovis Oncology, Inc. (NASDAQ:CLVS) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has issued a positive opinion recommending approval of PARP inhibitor, Rubraca (rucaparib). The company is seeking approval of the drug as monotherapy for the treatment of women with platinum-sensitive ovarian cancer with BRCA mutation.
Clovis expects a final decision from the EMA in the second quarter of 2018.
Rubraca is already approved in the United States for this indication.
Clovis’ shares have lost 15.8% so far this year, underperforming the industry ’s decline of 5.9% in that period.
The CHMP nod was based on positive objective response rate and duration of response data from two clinical studies, Study 10 and ARIEL 2, evaluating Rubraca in patients whose disease has progressed after two or more chemotherapies.
Following the potential approval of Rubraca in Europe, Clovis is planning to file a variation to the marketing application seeking approval in a broader maintenance indication. The application will include significantly improved progression free survival data from ARIEL 3 study. A similar application in under review in the United States.
Concurrently, Clovis also initiated an early access program for Rubraca in Europe as a treatment and maintenance therapy for recurrent ovarian cancer
Per the press release, a quarter of 65,000 patients diagnosed with ovarian cancer annually have BRCA mutation. The patients have limited treatment options available, which represents significant unmet need.
However, Clovis’ Rubraca will face competition from other PARP inhibitors including Tesaro, Inc.'s (NASDAQ:TSRO) Zejula and AstraZeneca's (NYSE:AZN) Lynparza as both these drugs are already approved to treat ovarian cancer in the EU. The drugs also enjoy advantage over Rubraca as they are approved in patients irrespective of the BRCA-mutation.
Meanwhile, a phase III confirmatory study, ARIEL4, is evaluating Rubraca compared with chemotherapy on patients, who have failed two prior lines of therapy. Clovis is also looking to expand Rubraca’s label into additional indications like prostrate, breast and pancreatic cancers among others either as monotherapy or in combination with other agents.
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