May 23, 2018
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FDA approves new drug for advanced melanoma

By Rob Stein, The Washington Post

WASHINGTON — The Food and Drug Administration Wednesday announced the approval of a new drug to treat advanced melanoma, a deadly form of cancer.

The drug, known as Zelboraf, was approved for patients with metastatic melanoma, the most life-threatening form of skin cancer and one that cannot be removed with surgery.

The drug is the latest in a new generation of “personalized” cancer-fighting drugs tailored to attack genetic vulnerabilities of malignancies. Zelboraf was approved only for tumors with a genetic mutation known as BRAF V600E. The drug was approved with a test that can determine if a patient’s cancer has the mutation.

The mutation produces a version of a protein that is normally involved in regulating cell growth. The protein is mutated in about half of patients with advanced melanoma. Zelboraf inhibits the activity of the mutated protein.

Zelboraf, which is marketed by Genentech of San Francisco, was reviewed under the FDA’s “priority review program,” which enables the agency to approve drugs quickly.

In a study involving 675 patients with late-stage melanoma with the mutation, 77 percent of those who received Zelboraf were still living, while only 64 percent of those who received a standard chemotherapy drug known as dacarbazine survived eight months, the FDA said.

“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, director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, in a statement.

Zelboraf can cause joint pain, rashes, hair loss, fatigue, nausea, and skin sensitivity. About 26 percent of patients developed a skin-related cancer known as cutaneous squamous cell carcinoma, which was surgically removed. Patients treated with Zelboraf should avoid sun exposure.

Melanoma is the leading cause of death from skin disease. About 68,130 new cases of melanoma are diagnosed and about 8,700 people die from the disease each year in the United States.

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