Clovis Oncology, Inc. (CLVS - Free Report) announced that the European Commission (“EC”) has conditionally approved its PARP inhibitor, Rubraca (rucaparib) as monotherapy for the treatment of platinum-sensitive and relapsing ovarian cancer patients with BRCA-mutation in third- or later-line setting. The approval was expected as the Committee for Medicinal Products for Human Use (“CHMP”) had issued a positive opinion in March.
The company is required to carry out certain confirmatory post-marketing commitments as part of the conditional approval.
The approval in Europe is based on positive data from two clinical studies, Study 10 and ARIEL 2, evaluating Rubraca in patients whose disease has progressed after two or more chemotherapies. Rubraca achieved an objective response rate of 64.6% in the platinum sensitive patient population.
Rubraca is already approved in the United States for this indication. In April, the drug was approved by the FDA as maintenance treatment in recurrent ovarian cancer patients irrespective of BRCA mutation in second-line setting. Following the approval of Rubraca as monotherapy, Clovis is planning to file a variation to the marketing application for the maintenance indication in the EU soon. The application will include significantly improved progression free survival data from ARIEL 3 study. The company has also initiated an early access program for Rubraca in Europe as a treatment and maintenance therapy for recurrent ovarian cancer for better accessibility of the drug to patients.
Clovis’ shares have lost 28.3% so far this year, underperforming the industry’s decline of 9.5% in that period. However, the recent European approval and label expansion in the United States last month are likely to boost sales, which may drive the stock up going forward.
However, Clovis’ Rubraca will face competition from other PARP inhibitors including Tesaro, Inc.'s (TSRO - Free Report) Zejula and AstraZeneca's (AZN - Free Report) Lynparza as both these drugs are already approved to treat ovarian cancer in the EU. The drugs also enjoy advantage over Rubraca as these 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.
Zacks Rank & Stock to Consider
Clovis currently carries a Zacks Rank #3 (Hold).
Aeglea BioTherapeutics, Inc. (AGLE - Free Report) is a better-ranked stock in the health care space, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aeglea’s loss estimates narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the last 30 days. The company delivered positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. Its share price has increased 92.1% so far this year.
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