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FDA Approves Second Melanoma Drug This Year

August 18, 2011

The US Food and Drug Administration (FDA) on Wednesday approved the cancer treatment drug Zelboraf, used to treat patients with late-stage or unresectable melanoma, the most dangerous form of skin cancer.

The drug specifically treats patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been tested on patients whose melanoma tests negative for the mutation by an approved FDA diagnostic.

Zelboraf is being approved with a test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAF V600E mutation.

Zelboraf, made by Roche, is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein.

“This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”

Researchers attribute the acceleration of new diagnoses of melanoma to longer life expectancies among the elderly and increased indoor tanning by the young. About 68,000 people in the US were diagnosed in 2010, with 8,700 deaths, according to the American Cancer Society.

The FDA in March approved a drug developed by Bristol-Myers Squibb that was the first drug shown to prolong survival in patients with advanced skin cancer. Zelboraf will provide a second option for melanoma patients with the mutated BRAF gene.

The FDA approved the drug based on a 675-patient study in which patients received either Zelboraf or a chemotherapy drug. Since the study began, 77 percent of people on Zelboraf are alive compared to 64 percent of those on the older drug.

“Today’s approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.

But, despite the higher survival rate, melanoma adapts quickly, and patients saw their tumors resume growth after an average of seven months.

Zelboraf treatments will cost more than $112,000 annually (or $56,400 for a six-month treatment plan).

Some of the most common side effects with use of Zelboraf included skin rashes, joint pain, diarrhea and hair loss. About 26 percent of patients developed a less serious form of skin cancer.

Advocates of melanoma treatment praised the FDA approval well ahead of the October 28 target date set up to complete its review. “The FDA’s quick action on this drug approval is important because it gives melanoma patients a new way to fight this deadly disease,” Timothy Turnham, director of the Melanoma Research Foundation, told Associated Press in a statement.

Zelboraf is being approved with a Medication Guide to inform health care professionals and patients of Zelboraf’s potential risks and side effects.

Zelboraf was co-developed by Roche’s San Francisco-based Genentech unit and Japanese drugmaker Daiichi Sankyo. The companies also plan to co-promote the drug in the US. Zelboraf is currently under review in the European Union and some other countries around the world.

Roche said Wednesday the drug would be available in a few weeks.

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