YES BRAF = VEMURAFENIB
Recently presented encouraging data from a phase III trial (BRIM 3) on BRAF V600 mutation-positive metastatic melanoma candidate, vemurafenib (RG7204, PLX4032), at the annual meeting of the American Society of Clinical Oncology (ASCO).
The BRIM 3 study was conducted to compare vemurafenib with dacarbazine (chemotherapy) in patients with previously untreated BRAF V600 mutation-positive, unresected, locally advanced or metastatic melanoma (skin cancer).
Upon comparison with chemotherapy, the study results demonstrated that patients on vemurafenib experienced a significant improvement in overall survival, with the risk of death reducing by 63%. The study also met the co-primary endpoint of reducing the risk of disease aggravation by 74% compared with chemotherapy.
Last month, Roche submitted a new drug application (NDA) to the US Food and Drug Administration (FDA), for the use of vemurafenib to treat patients with BRAF V600 mutation-positive metastatic melanoma. Roche also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA), for similar use of the drug.
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