The skin cancer treatment is the first and only personalised medicine that allows patients with BRAF V600 mutation-positive metastatic melanoma to live significantly longer.
Hal Barron, Chief Medical Officer and Head, Global Product Development, said the approval is “important news” as Zelboraf “significantly improves patient survival”.
Zelboraf is designed to target and inhibit mutated forms of BRAF found in approximately half of all cases of skin cancer.
In pivotal clinical trials, it demonstrated patient survival in previously untreated and treated those with advanced melanoma who tested positive for BRAF V600 mutations in Roche’s cobas 4800 BRAF V600 Mutation Test.
Data from the Phase III BRIM3 trial showed that the risk of death fell by 63% in people receiving Zelboraf compared to those receiving standard first-line treatment.
Post-hoc analysis of BRIM3 data with a follow-up compared to previous analyses also showed Zelboraf significantly improved survival by a median overall survival (OS) of 13.2 months compared to 9.6 months for chemotherapy.
Last year, the medication became the first and only personalised medicine approved by the FDA for the same indication. It has also recently been approved for use in Switzerland, Brazil, Israel, Canada and New Zealand.