Clovis Oncology, Inc. (CLVS - Free Report) recently announced that the FDA has granted approval to label expansion of its PARP inhibitor, Rubraca (rucaparib). The drug is now approved as a maintenance treatment in recurrent ovarian cancer patients who have received one prior platinum-based chemotherapy. The drug can now also be prescribed irrespective of BRCA-mutation in the second-line setting.
The FDA approval was based on data from the confirmatory phase III study — ARIEL 3 which showed that Rubraca led to significant improvement in progression-free survival in such patients.
Please note that Rubraca had received accelerated approval for the treatment of advanced BRCA-mutant ovarian cancer in third or later line setting in December 2016. With the latest approval, the accelerated approval was converted to regular one for this indication. The drug is under review in Europe for this indication with a decision expected in this quarter.
Shares of Clovis were up 5.9% on Mar 6, after the news surfaced. However, the stock has lost 18.4% so far this year, underperforming the industry’s decline of 11.8%.
With the latest approval, Rubraca comes at par with other approved PARP inhibitors for treatment of ovarian cancer — AstraZeneca’s (AZN - Free Report) Lynparza and TESARO’s (TSRO - Free Report) Zejula. All the drugs are now approved in patients irrespective of the BRCA-mutation status, creating a level playing field for all the players.
Pfizer (PFE - Free Report) is also evaluating its PARP inhibitor, talazoparib, in a phase I study in several advanced or recurrent solid tumors.
Moreover, earlier this February, the National Comprehensive Cancer Network (“NCCN”) added Rubraca as maintenance therapy for third or later line ovarian cancer patients to its clinical practice guidelines in oncology ovarian cancer.
The year 2018 has started well for Clovis with a positive recommendation for Rubraca’s approval in Europe in third or later line ovarian cancer patients, addition to the NCCN guidelines and the latest label expansion in the United States. Moreover, after a potential approval in Europe, Clovis will seek further approval of the drug as maintenance therapy in the expanded patient population.
These positive developments are expected to boost the company’s top line. However, it remains to be seen how the three PARP inhibitors perform in an equally competing field.
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.
Clovis currently carries a Zacks Rank #4 (Sell). You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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