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FDA Approves Novel Melanoma Drug
Date:8/17/2011

determine if a patient's melanoma cells have the BRAF V600E mutation. The first-of-a-kind test is called the cobas 4800 BRAF V600 Mutation Test.

"We now have the capability to analyze a patient's melanoma tumor for the genetic mutation BRAF and use the targeted treatment Zelboraf to attack the tumor, shrink it and stop the progression of this deadly disease," Pavlick said. "The drug comes in a simple pill form, taken twice a day."

According to the FDA, Zelboraf's approval came as part of an accelerated review program, and was based on a single international trial of 675 patients with late-stage melanoma with the BRAF V600E mutation who did not receive prior treatment. In the trial, patients received either Zelboraf or another cancer drug called dacarbazine. The median survival time after treatment was 8 months (64 percent still living) for patients in the dacarbazine group but has not been reached for patients in the Zelboraf group (77 percent still living), the agency said.

Still, not every person with melanoma will benefit from Zelboraf, and much more research is needed, the MRA's Selig said.

"While the entire melanoma community applauds the breakthrough exemplified by vemurafenib [Zelboraf], the data demonstrate that tumors have the ability to develop resistance to the drug, causing patients to relapse," she noted. "Additionally, because some patients with BRAF mutation do not respond to the drug and about half of patients do not have the mutation, finding additional new targets remains an ongoing urgent need."

The most common side effects among patients taking Zelboraf were joint pain, rash, hair loss, fatigue, nausea and sun-related skin sensitivity. About 26 percent of the patients taking Zelboraf developed cutaneous squamous cell carcinoma, the second most common form of nonmelanoma skin cancer. It was managed with surgery.

Patients who take Zelboraf should avoid sun exposure, the FDA said.

According to the American
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