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Clovis (CLVS) Stock Up on FDA Priority Review for Rucaparib
Clovis Oncology, Inc.’s shares shot up 27.2% on news that the FDA has granted priority review status to the company’s regulatory application for its experimental cancer drug, rucaparib.
Clovis is looking to get rucaparib approved for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors including both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies. Rucaparib has Breakthrough Therapy Designation for this indication and the company, which finished submitting the NDA in late June, had sought accelerated approval. The EU regulatory application for the candidate for a comparable ovarian cancer indication will be submitted in the fourth quarter of 2016.
Foundation Medicine, Clovis’ companion diagnostic partner, also submitted its regulatory application for its FoundationFocus CDxBRCA to the FDA in Jun 2016. The test has been designed for the identification of tumor BRCA mutations, including germline and somatic BRCA mutations.
With the FDA granting priority review, a response from the agency should be out by Feb 23, 2017. Approval would be a huge boost for the company given the immense commercial potential in the target market and the demand for PARP inhibitors. Rucaparib is an oral, potent small molecule inhibitor of PARP1-3 and is being evaluated for additional indications as well.
CLOVIS ONCOLOGY Price
CLOVIS ONCOLOGY Price | CLOVIS ONCOLOGY Quote
The company has completed enrollment in a pivotal maintenance study (ARIEL3) on rucaparib in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, with data expected in the fourth quarter of 2017. Positive data would allow the company to seek label expansion into second line maintenance therapy.
The ARIEL4 confirmatory study in advanced ovarian cancer is scheduled to start in the second half of 2016. The study will evaluate rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of treatment.
Rucaparib also has the potential to be developed for other types of cancer including solid tumor types with BRCA and HRD populations, including prostate, breast and gastroesophageal cancers.
According to The American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. The American Cancer Society estimates that more than 22,000 new cases of ovarian cancer will be diagnosed in the U.S. in 2016.
There is significant need for new treatment options considering that one in four women with ovarian cancer have a germline or somatic BRCA mutation.
Clovis is a Zacks Rank #2 (Buy) stock. Actelion Ltd. , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) are better-ranked with all three carrying a Zacks Rank #1 (Strong Buy).
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