Clovis Oncology, Inc. (CLVS - Free Report) announced that the European Medicines Agency ("EMA") has accepted its type II variation to the marketing authorization seeking label expansion of Rubraca in Europe.
We remind investors that Rubraca was approved in Europe as monotherapy for the treatment of platinum-sensitive and relapsing ovarian cancer patients with BRCA-mutation in third- or later-line setting in May. With the latest application, the company is seeking label expansion of the drug as maintenance treatment for ovarian cancer patients irrespective of BRCA-mutation and who are in a complete or partial response to platinum based chemotherapy.
A potential approval for the label expansion will boost the prospect of the drug in Europe as it will reach a wider population base of patients with ovarian cancer.
Rubraca is approved for the expanded indication in the United States with approval as maintenance treatment received in April.
Clovis’ shares have declined 33% so far this year compared with the industry’s 6.4% decline.
The regulatory application includes promising data from the confirmatory phase III study, ARIEL 3. The drug showed a significant delay in recurrence of the disease in BRCA mutant or HRD positive ovarian cancer patients in the study.
Rubraca competes with AstraZeneca’s (AZN - Free Report) Lynparza and Tesaro, Inc.'s (TSRO - Free Report) Zejula. Lynparza and Zejula have an advantage over Rubraca as the drugs are already approved in patients irrespective of BRCA-mutation status.
Meanwhile, an early-stage study is being conducted by Pfizer (PFE - Free Report) , on its PARP inhibitor, talazoparib, in several advanced or recurrent solid tumors.
The year 2018 is progressing well for Clovis with two regulatory approvals for Rubraca.The National Comprehensive Cancer Network added the drug as maintenance therapy for third or later-line setting to its clinical practice guidelines for ovarian cancer.
These positive developments will certainly boost sales of the drug, driving the company’s topline going forward.
Apart from these, a late-stage confirmatory study is evaluating Rubraca compared with chemotherapy on patients in third or later-line settings. The company is also developing the drug in additional indications like prostrate, breast and pancreatic cancers.
Clovis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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