Today, the FDA approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test.  Zelboraf is the first and only FDA-approved personalized medicine for people with BRAF V600E mutation-positive metastatic melanoma.  This BRAF protein is found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer.

   Also today, the FDA also approved the diagnostic test developed by Roche to help identify patients eligible for Zelboraf treatment (the cobas 4800 BRAF V600 Mutation Test).

   For Richard Kaminski, a Waterbury, Conn. resident, this is a significant day.  Richard, an avid gardener, was diagnosed with metastatic melanoma in 2009 after going to the doctor for a persistent cough caused by a tumor in his lung.  After his initial treatment failed, Richard was referred to Dr. Anna Pavlick at NYU, who tested Richard’s tumor for the BRAF mutation.  After testing positive, she enrolled Richard in a clinical trial with Zelboraf.  Since entering the clinical trial, Richard’s tumor shrunk by 95 percent and he was able to see the birth of his first granddaughter in May.

    Approximately 1,700 men and 1,300 women are diagnosed with melanoma each year in New York State. About 8,500 men and 6,600 women who currently reside in New York have had diagnoses of melanoma within the past five years. And those numbers are rising.