FDA approves Zelboraf (vemurafenib) for advanced skin cancer

July 15, 2017

Early findings from that phase-three clinical trial were presented in Chicago at June's conference of the American Society of Clinical Oncology (ASCO). Lead author Paul Chapman, a physician at Memorial Sloan-Kettering Cancer Center in New York, called Zelboraf ???the first successful melanoma treatment tailored to patients who carry a specific gene mutation in their tumor.???

Side effects include joint pain, rash, hair loss, fatigue, nausea, and sensitivity to sun exposure, and those taking it should stay out of the sun, the FDA said.

Roche said the drug should be available in the United States in two weeks, and said it has submitted new drug applications for Zelboraf in the European Union, Australia, New Zealand, Brazil, India, Mexico and Canada.

However, Turnham warned that while the drug can work wonders for some patients, its effects do not typically last. ???For a lot of people, it works like magic. Two weeks after taking Zelboraf, the cancer is gone. It's amazing the way it melts tumors away. But the median response time is six months, then the tumors start coming back. There is a real need to find ways to extend that response time, perhaps by combining it with other drugs,??? he said.

The National Cancer Institute says 68,130 new cases of melanoma were diagnosed in the United States last year and about 8,700 people died from the disease. According to the World Health Organization, skin cancer leads to 66,000 deaths annually worldwide, 80 percent of which involve melanomas. More than half the patients are under age 59.