Clovis Oncology, Inc. (CLVS - Free Report) announced that the FDA has granted Breakthrough Therapy designation for its cancer drug, Rubraca (rucaparib). The designation was granted for treating BRCA1/2 mutated metastatic castration resistant prostate cancer (mCRPC), based on initial data from phase II TRITON2 study. Currently, the study is evaluating the drug in mCRPC patients with BRCA mutations and ATM mutations.
Later this month, data will be presented at the European Society for Medical Oncology (“ESMO”) Congress to be held in Germany.
We note that the Breakthrough Therapy designation from the FDA should accelerate the development and review of drugs that are intended to treat serious or life-threatening diseases.
Following the latest announcement, shares of the company jumped 7.7% on Oct 2. However, Clovis’ stock has lost 53.8% so far this year compared with the industry’s 1.8% decline.
Rubraca, a PARP-inhibitor, is already approved for treating ovarian cancer in second-line setting in the United States, where it competes with AstraZeneca’s (AZN - Free Report) Lynparza and TESARO’s (TSRO - Free Report) Zejula. Approval for second-line maintenance treatment was granted by the FDA in April.
A regulatory application for the similar maintenance treatment for ovarian cancer is under review in Europe, where it is approved for platinum-sensitive and relapsing ovarian cancer patients with BRCA-mutation in third- or later-line setting.
Notably, Clovis is focused on developing the drug in different types of ovarian cancer along with other types of cancer.
While a phase III study – TRITON 3 – is also evaluating Rubraca in mCRPC, a phase II ATLAS study is evaluating the drug in bladder cancer.
This apart, Clovis has a collaboration agreement with Merck (MRK - Free Report) and Bristol-Myers to develop Rubraca in combination with their PD-1/ PDL1 inhibitors for treating several cancer indications.
In the first half of 2018, Rubraca’s sales have almost doubled compared with the figure registered a year ago. Successful development of the drug in the ongoing studies will boost its prospect further.
Clovis currently has 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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