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Assignment:Cobimetinib (Cotellic) is an inhibitor

Assignment:Cobimetinib (Cotellic) is an inhibitor of the mitogen-activated protein kinase(MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. These proteins are upstreamregulators 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 proteinplays a role in regulating the MAPK/ERK signaling pathway, which affects cell division. In patients withmelanoma containing BRAF V600E or BRAF V600K mutations, the ERK pathway is constitutivelyactivated, resulting in promotion of tumor growth.Background Information:On November 10, 2015, FDA issued an Approval Letter allowing Genentech, Inc. to market thekinase inhibitor, Cotellic (cobimetinib), for use in combination with vemurafenib for the treatment ofpatients with BRAFV600E/K mutation positive unresectable or metastatic melanoma. Cobimetinib is aninhibitor of MEK1 and MEK, which are ubiquitously expressed proteins that participate in theMAPK/ERK signal transduction cascade. MEK proteins propagate signals between the small GTPaseRas, 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 is a valuable resource for Regulatory Affairs personnel in the pharmaceuticalindustry. Aside from new drug Approval Letters and Labeling Revisions, FDA summaries of nonclinical,medical, chemistry, statistical, clinical, and biopharmaceutics reviews are made publically availablefollowing marketing approval. Reviewing FDA approval decisions and the drug development programsassociated with such decisions may provide insight and precedence to other pharmaceutical companiestargeting the same indication or mechanism of action for their drug candidates. Regulatory Affairspersonnel may use this information to contribute to a corporate strategy shaped with regulatory input.Using, provide a broad, 2-3 page overview of the nonclinical studies GenentechPharmaceuticals carried out for Cotellic prior to receiving marketing approval. Please include briefdescriptions of carcinogenicity, genotoxicity, reproductive, pharmacokinetic, and pharmacology studiesperformed. For each type of study, explain the potential timeframe during drug development when thatstudy may have been carried out (for example, whether that study would need to be completed prior tostarting clinical trials, or could be performed while clinical trials are ongoing), as well as its majorobjective. Include an overview of Cotellic and melanoma with BRAF V600E/K mutations in theintroductory paragraph, and discuss the goals of nonclinical development and adequacy of the nonclinicaldevelopment program for Cotellic in the conclusion.

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