Clovis (CLVS) Submits SNDA For Ovarian Cancer Drug Rubraca
Zacks Investment Research | Oct 09, 2017 10:50PM ET
Clovis Oncology (NASDAQ:CLVS) announced the submission of a supplemental New Drug Application (sNDA) for Rubraca (rucaparib) to the FDA. The sNDA is looking to expand Rubraca’s label as a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer.
We remind investors that Rubraca, a PARP inhibitor, had received accelerated approval as monotherapy in advanced ovarian cancer patients with deleterious BRCA mutation, treated with two or more chemotherapies in December 2016. Clovis is conducting confirmatory studies to convert this approval to a full approval.
Clovis’ stock was up 1.8% in after-market trading following the news. In fact, shares of the company are up almost 88% so far this year, significantly outperforming the industry ’s gain of 13.9% in that period.
The sNDA was submitted based on promising data from the confirmatory phase III study – ARIEL 3 – announced in June this year. Rubraca demonstrated a meaningful impact in delaying disease recurrence in advanced ovarian cancer patients who are either BRCA mutant or HRD positive.
The company is committed to expand the label of Rubraca for a broader population of women with ovarian cancer, which is evident from the fact that it filed the sNDA within four months of its top-line data announcement. Moreover, Clovis offered its common stock in June to raise an aggregate of $300 million in net proceeds, which it plans to use partly for promotional and marketing expense associated with Rubraca.
Meanwhile, Rubraca as a monotherapy is also under review in the EU for treating advanced ovarian cancer. Clovis is planning to file a marketing authorization application in early 2018 for maintenance treatment following the potential approval as monotherapy.
A potential approval in the EU and label expansion in the United States is expected to boost the potential of the drug. It has generated sales of nearly $15 million in the first half of 2017, following its approval in December last year. Also, during this period, more than 1000 patients started using the therapy.
However, Clovis’ Rubraca will face competition from other PARP inhibitors, which include Tesaro, Inc.’s (NASDAQ:TSRO) Zejula and AstraZeneca plc’s (NYSE:AZN) Lynparza.
Meanwhile, the second phase III confirmatory study, ARIEL4, is evaluating Rubraca versus chemotherapy in 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.
Several clinical studies were initiated in early 2017, including TRITON2 and TRITON3 in prostate cancer and a Tecentriq-Rubraca combination study in gynecologic cancers, which is sponsored by Roche Holding (SIX:ROG) AG (OTC:RHHBY) .
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