EMA Advisory Committee Recommends Roche’s Melanoma DrugBy
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for Roche’s Cotellic (cobimetinib), when used in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma.
Cotellic recently received approval in Switzerland for use in combination with Zelboraf as a treatment for patients with advanced melanoma, and the US Food and Drug Administration is expected to make a decision on Roche's new drug application for the combination before the end of the year.
Zelboraf was the first approved treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test, such as Roche's cobas 4800 BRAF Mutation Test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma. Cotellic (cobimetinib) is designed to selectively block the activity of MEK,10 one of a series of proteins inside cells that make up the MAPK signaling pathway that helps regulate cell division and survival.11 In the majority of patients, resistance to BRAF-inhibitor monotherapy will eventually occur through re-activation of the MAPK pathway via MEK.12 Cotellic was developed to overcome resistance to BRAF-inhibition and prevent re-activation of the pathway. Cotellic binds to MEK, while Zelboraf binds to mutant BRAF, to interrupt abnormal signalling that can cause tumors to grow.
Cotellic is also being investigated in combination with several investigational medicines, including immunotherapy, in several tumor types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.