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The Food and Drug Administration announced on August 17 the approval of vemurafenib, a highly anticipated metastatic melanoma therapy that targets the BRAF V600E mutation found in 40%-60% of patients.

The agency also approved the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic test designed to help determine if a patient’s melanoma cells carry the BRAF V600E mutation.

Vemurafenib is the second therapy to prolong the lives of patients with metastatic melanoma. The first, a slow-acting immunotherapy called ipilimumab (Yervoy), was approved in March 2011.

Clinical trials have shown that vemurafenib (better known as PLX4032) can produce rapid remission in patients at risk of death from metastatic melanoma.

Vemurafenib is not a panacea, as only about half of patients with BRAF V600E mutations have responded, and in the early studies almost all eventually relapsed. However, the drug has produced delays in recurrence and prolongations of overall survival that are clinically and statistically significant.

"This is a bright day for many melanoma patients," Dr. Jeffrey A. Sosman, a professor of medicine at Vanderbilt-Ingram Cancer Center in Nashville said in response to the FDA announcement.

"But it is only the start, and we have to continue to enroll patients onto clinical trials in order to build upon this exciting advance. It is only the beginning," added Dr. Sosman, an investigator in the BRIM-3 trial that led to approval of vemurafenib.

Early results of the pivotal phase III BRIM-3 trial, presented at the American Society of Clinical Oncology (ASCO) in June, and published simultaneously in the New England Journal of Medicine (2011;364:2507-16) , showed that vemurafenib reduced the relative risk of death by 63% in comparison with dacarbazine (DTIC), a standard but ineffective therapy, at a median follow-up of 3 months.

The randomized, open-label study screened 2,107 patients with unresectable stage III or IV melanoma for BRAF mutations, which were found in 47% of patients. It accrued 675 patients from January 2010 though December 2010, but some had not been in the study long enough to be included in the reports, as the trial was stopped based on early positive results.

Among the findings were estimates that 84% of patients treated with oral vemurafenib but only 64% of those given DTIC would be alive at 6 months. Vemurafenib’s hazard ratio for death was 0.37 (P less than .0001). An analysis of progression-free survival showed a 74% reduction in the risk of progression (HR 0.26, P less than .0001).

Median time to progression was 5.3 months with vemurafenib versus 1.6 months with DTIC, Dr. Paul Chapman of Memorial Sloan-Kettering Cancer Center in New York City and colleagues reported. Median overall survival had not been reached in the vemurafenib arm of BRIM-3, but Dr. Chapman expressed optimism that the advantage would hold up over time, as the Kaplan Meier survival curve mirrored results from the precursor BRIM-2 trial.