Roche melanoma of new drugs approved by the FDA Cotellic

Swiss pharmaceutical giant Roche (Roche) cancer drug pipeline news came recently in the United States regulation, the company has developed an oral anti-cancer drugs targeting Cotellic (cobimetinib) to obtain FDA approval, Roche's own cancer drug marketed jointly Zelboraf (vemurafenib, Weiluofeini) for BRAF V600E mutation or V600K positive unresectable or metastatic melanoma patients. Cotellic also marks Roche receives FDA in the past five years, approved the first seven drugs. In the EU, Cotellic harvested in September this year, the European Medicines Agency (EMA) Committee for Medicinal Products for human use (CHMP) recommended approval of positive opinions, the EU is expected to get approval by the end of 2015. Before, Cotellic August this year was approved by Swissmedic. It should be noted, Cotellic and does not apply to patients with melanoma Zelboraf BRAF gene normal.
Cotellic approved, is based on Phase III data key coBRIM research, this study is an international, randomized, double-blind, placebo-controlled phase III study, in 495 cases previously untreated, BRAF V600 mutation carrying unresectable Locally advanced or metastatic melanoma patients conducted to investigate the Cotellic (60mg dose once daily) combined with Zelboraf (960mg doses, twice daily) efficacy and safety. Data show that, compared with Zelboraf + placebo group, deterioration Cotellic + Zelboraf combination therapy group of diseases or significantly reduce the risk of death, progression-free survival (median PFS: 12.3 months vs 7.2 months, p <0.001) was significantly prolonged. In addition, an interim analysis of data, compared with Zelboraf + placebo group, Cotellic + Zelboraf combination therapy group was significantly prolonged overall survival (OS, p = 0.0019), objective response rate (ORR: 70% vs 50%, p <0.001), complete remission rate (16% vs 11%) higher. The study's final overall survival (OS) analysis of the data will be submitted to the 2015 International Conference on Melanoma Research Society (SMR), held 18-21 November 2015 in California.
cobimetinib is an oral small molecule MEK inhibitors, MEK is a protein kinase, is a part of RAS-RAF-MEK-ERK signaling pathway, this pathway can promote the division and cell survival in human cancer (including melanoma) in often active. cobimetinib designed to selectively block the activity of MEK protein, thereby blocking signal transduction pathways downstream.