Melanoma Drug, Vemurafenib, Approved By US FDA

The drug vemurafenib (Zelboraf) for metastatic melanoma in patients who test positive for the BRAF mutation, has been approved by the U.S. Food and Drug Administration. Vemurafenib, a BRAF-inhibitor, is a personalized investigational drug designed to specifically inhibit the activity of the mutant BRAF protein that is present in almost half of all melanoma cases, the most lethal and aggressive form of skin cancer.

Jeffrey Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt said:

“This is a great success story. To find a mutation and develop a test to enable widespread testing and matching a patient to the treatment is just the kind of personalized medicine we want to be known for here at the cancer center.”

Weber was a researcher on the trial that administered BRIM2, a global, single-arm, multicenter, open-label Phase II investigation involving 132 patients with previously treated BRAF V600 mutation-positive metastatic melanoma. The primary endpoint of the investigation was overall response rate as evaluated by an independent review committee. Trial administrators reported that in 52% of trial participants, vemurafenib shrank tumors, they also spent a median of 6.2 months without their disease getting worse (median PFS).

Cutaneous squamous cell carcinoma, a common skin cancer treated by local excision (minor surgery done in a physician’s office), was the most frequent Grade 3 adverse event. The most common adverse events were rash, increased sun sensitivity, joint pain, hair loss and fatigue. Potential serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats, and allergic reactions.

Written by Grace Rattue

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