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First personalised skin cancer drug approved


The first and only personalised skin cancer medicine allows people with BRAF V600 mutation-positive metastatic melanoma to live significantly longer.


The European Commission has approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer. 


Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.


“Today’s approval is important news for people with BRAF mutation-positive metastatic melanoma as Zelboraf significantly improves patient survival and exemplifies the benefits that Roche’s personalised approach to medicine can provide for patients, physicians and society,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development.


In pivotal clinical trials, Zelboraf is the only treatment to benefit patient survival in both previously untreated and previously treated people with advanced melanoma who tested positive for BRAF V600 mutations using the Roche cobas 4800 BRAF V600 Mutation Test.In the pre-specified interim analysis of the Phase III BRIM3 trial, the risk of death was reduced by 63 percent for people who received Zelboraf compared to those who received standard first-line treatment (hazard ratio [HR]=0.37, p<0.0001).


In a post-hoc analysis of BRIM3 data with a longer follow up compared to previous analyses, including cross-over of patients from the placebo to the active treatment arm, Zelboraf significantly improved survival over standard first-line treatment by providing a median overall survival (OS) of 13.2 months compared to 9.6 months for chemotherapy (hazard ratio [HR]=0.62).



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