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FDA Grants Priority Review to Potential Liver Cancer Therapy

By Matthew Mahady
Published: Wednesday, Jun 30, 2010
An oral therapy currently utilized in the treatment of advanced kidney cancer may be on the threshold of obtaining a major new indication.

Bayer HealthCare Pharmaceuticals, Wayne, New Jersey, and Onyx Pharmaceuticals, Inc., Emeryville, California, recently reported that a supplemental New Drug Application (sNDA) seeking FDA approval to utilize sorafenib tablets, branded Nexavar, in the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, has been accepted for review.

In addition to accepting the sNDA, the FDA elected to grant it Priority Review status, which expedites and truncates the regulatory review process. In most cases, in accordance with stated agency guidelines and goals, the FDA takes action on Priority Review applications within six months of the date when they are received. The Priority Review designation is exclusively reserved for therapies that are classified as investigational agents and/or treatments that address unmet medical needs.

In a recently released press release, Susan Kelley, MD, Vice President, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals, explained, “if approved, Nexavar would be the first FDA-approved therapy for patients battling this devastating disease.”

The sNDA submission is based on Phase III trial data comparing Nexavar with placebo. Findings linked Nexavar with a 44% rate of extended overall survival. No significant differences in serious adverse event rates between the Nexavar and placebo-treated groups were observed.

Results from the Asia-Pacific Liver Cancer Trial, a separate Phase III study initiated after the submission of Nexavar’s sNDA has provided further corroboration of the drug’s ability to improve survival. After a review conducted by an independent data monitoring committee, which found that Nexavar significantly improved overall survival, progression- free survival, and time to progression in patients with advanced HCC, the trial was terminated early in order to allow all patients to access the therapy (as per the recommendations of the committee).

Due to the high unmet need in HCC, industry observers suggest that it is likely that Nexavar will be granted eventual FDA approval. Should this occur, Nexavar’s sales are expected to be significantly boosted, since the drug is currently only indicated for treatment of metastatic renal cell carcinoma.

Nexavar, a small molecule drug, targets both the tumor cell and tumor vasculature. The agent has been shown to target members of two classes of kinases known to be involved in two important processes—cell proliferation and angiogenesis—that enable cancer growth. Thus, the agents mechanism of action works to attack tumors on multiple fronts, starving it of blood supply, interfering with cell signaling that spurs tumor growth, and preventing cell division.

Nexavar is currently undergoing evaluation by Bayer, Onyx, international study groups, government agencies, and individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non–small cell lung cancer. In addition, Bayer and Onyx recently confirmed plans to execute a Phase III study of Nexavar in the adjuvant treatment of HCC following the complete removal of early-stage liver cancer.


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