Clovis Oncology, Inc. (CLVS) Rockets on FDA Acceptance of New Drug Application

Shares of Boulder, Colorado, based Clovis Oncology, Inc. (CLVS) rose sharply on Tuesday, against the backdrop of slightly higher day in stocks overall. Clovis Oncology's stock was up 27.24%, rising $4.93 per share, to close at $23.03, on volume of 17,131,395 shares. The company announced that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for accelerated approval of for its new ovarian cancer drug, granting it priority review status.

Founded in 2009, Clovis Oncology, Inc. is a biopharmaceutical company that acquires, develops and commercializes cancer treatments in the United States, Europe and other international markets.
The company has three product candidates in its clinical development pipeline: Rociletinib, Rucaparib and Lucitani. The stock trades on the NASDAQ Exchange.

On Tuesday, Clovis Oncology announced that the FDA accepted the company's NDA for accelerated approval of its drug, rucaparib, granting priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. Clovis completed its NDA submission of rucaparib to the FDA in late June. The drug was submitted for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies.

The study showed that 54% of patients with recurrent ovarian cancer responded to the Clovis Oncology's rucaparib treatment. Rucaparib had been granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015.

More than 22,000 women will be diagnosed with ovarian cancer in the U.S. this year, and there are often no clearly identifiable initial symptoms. In as many as 85% of ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed and can be treated. It is the fifth highest cancer in regard to cancer deaths and causes more deaths than any other cancer of the female reproductive system. One in four women with ovarian cancer have a germline or somatic BRCA mutation, and new treatment options are needed to treat unique patient populations.

“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis,” said Clovis Oncology President and CEO Patrick J. Mahaffy. “There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”

According to Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center, “Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients...”

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Published on Aug 24, 2016
By Kevin Mercadante

Copyrighted 2020. Content published with author's permission.

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