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Assignment: Cobimetinib (Cotellic) is an inhibitor of the mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. These proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF is a member of the Raf kinase family of growth signal transduction protein kinases. This protein plays a role in regulating the MAPK/ERK signaling pathway, which affects cell division. In patients with melanoma containing BRAF V600E or BRAF V600K mutations, the ERK pathway is constitutively activated, resulting in promotion of tumor growth. Background Information: On November 10, 2015, FDA issued an Approval Letter allowing Genentech, Inc. to market the kinase inhibitor, Cotellic (cobimetinib), for use in combination with vemurafenib for the treatment of patients with BRAFV600E/K mutation positive unresectable or metastatic melanoma. Cobimetinib is an inhibitor of MEK1 and MEK, which are ubiquitously expressed proteins that participate in the MAPK/ERK signal transduction cascade. MEK proteins propagate signals between the small GTPase Ras, its downstream immediate effector Raf and the ERK1/2. Cobimetinib is a kinase inhibitor, consistent with the established pharmaceutical class for other drugs with this type of activity. Prompt: Drugs@fda.gov is a valuable resource for Regulatory Affairs personnel in the pharmaceutical industry. Aside from new drug Approval Letters and Labeling Revisions, FDA summaries of nonclinical, medical, chemistry, statistical, clinical, and biopharmaceutics reviews are made publically available following marketing approval. Reviewing FDA approval decisions and the drug development programs associated with such decisions may provide insight and precedence to other pharmaceutical companies targeting the same indication or mechanism of action for their drug candidates. Regulatory Affairs personnel may use this information to contribute to a corporate strategy shaped with regulatory input. Using Drugs@fda.gov, provide a broad, 2-3 page overview of the nonclinical studies Genentech Pharmaceuticals carried out for Cotellic prior to receiving marketing approval. Please include brief descriptions of carcinogenicity, genotoxicity, reproductive, pharmacokinetic, and pharmacology studies performed. For each type of study, explain the potential timeframe during drug development when that study may have been carried out (for example, whether that study would need to be completed prior to starting clinical trials, or could be performed while clinical trials are ongoing), as well as its major objective. Include an overview of Cotellic and melanoma with BRAF V600E/K mutations in the introductory paragraph, and discuss the goals of nonclinical development and adequacy of the nonclinical development program for Cotellic in the conclusion.



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