Vemurafenib and Companion Diagnostic Test Approved by FDA

Vemurafenib (Zelboraf), a drug for the treatment of patients with late-stage or unresectable melanoma, the most dangerous type of skin cancer, has been approved by the U.S. Food and Drug Administration. Melanomas cause an estimated 8700 deaths in the U.S. each year. 

 

Vemurafenib is indicated for the treatment of patients with melanomas with the gene mutation BRAF V600E as detected by the cobas 4800 BRAF V600 Mutation Test. This companion diagnostic was approved along with verumafenib. The drug has not been studied in patients whose melanoma tests negative for that mutation.

Normally, the BRAF protein is involved in regulating cell growth but is mutated in about 50% of patients with late-stage melanomas. Vemurafenib is a BRAF inhibitor with an ability to impede the function of the V600E-mutated BRAF protein.

 

The safety and effectiveness of vemurafenib were established in a single international trial involving 675 late-stage melanoma patients with the BRAF V600E mutation who had not received prior therapy. In the study, patients received either vemurafenib or dacarbazine, another anticancer therapy.

 

Overall survival was the primary end point of the study. At this time, the median survival of patients receiving vemurafenib has not been reached, however, 77% are still alive. The median survival for those who received dacarbazine was 8 months, with 64% still alive.

 

“Today’s approval of Zelboraf (vemurafenib) 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, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA Center for Devices and Radiological Health.

 

Joint pain, rash, hair loss, fatigue, nausea, and photosensitivity were the most common side effects reported in patients receiving vemurafenib. Because about 24% of patients developed cutaneous squamous cell carcinoma (which was managed with surgery), patients treated with vemurafenib should avoid sun exposure.

 

Vemurafenib (Zelboraf) is being approved with a Medication Guide to inform healthcare professionals and patients of the drug’s potential risks.

 

Source: FDA Press Release