FDA Approves New Treatment Option for Advanced Melanoma

November 10th, 2015

On November 10, 2015, the FDA approved Cotellic (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive advanced melanoma, for use in combination with Zelboraf (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene.

News in brief

  • The pivotal coBRIM study showed Cotellic plus Zelboraf reduced the risk of disease worsening or death (progression-free survival; PFS) by about half and helped people live significantly longer (overall survival; OS) compared to Zelboraf alone
  • This FDA approval underscores the important role of targeted medicines to help people with BRAF V600 mutation-positive advanced melanoma

Supporting Information

Sandra Horning, M.D.

“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone. With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”