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Cotellic FDA Approval History

Last updated by Judith Stewart, BPharm on March 16, 2023.

FDA Approved: Yes (First approved November 10, 2015)
Brand name: Cotellic
Generic name: cobimetinib
Dosage form: Tablets
Company: Genentech, Inc.
Treatment for: Melanoma, Histiocytic Neoplasm

Cotellic (cobimetinib) is an MEK inhibitor for the treatment of melanoma and histiocytic neoplasms.

  • Cotellic is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib; and as a single agent for the treatment of adult patients with histiocytic neoplasms.
  • Cotellic tablets are taken once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Doses can be taken with or without food.
  • Warnings and precautions associated with Cotellic include new malignancies, hemorrhage, cardiomyopathy, severe skin rash, serous retinopathy and retinal vein occlusion, hepatotoxicity, rhabdomyolysis, severe photosensitivity reactions, and embryo-fetal toxicity.
  • Common side effects in patients treated for melanoma include diarrhea, photosensitivity reactions, nausea, pyrexia, and vomiting. Common laboratory abnormalities are increased GGT, increased CPK, hypophosphatemia, increased ALT, lymphopenia, increased AST, increased alkaline phosphatase, and hyponatremia.
    Common side effects in patients treated for histiocytic neoplasms include acneiform dermatitis, diarrhea, infection, fatigue, nausea, edema, dry skin, maculopapular rash, pruritus, dyspepsia, vomiting, dyspnea and urinary tract infections. Common laboratory abnormalities include hyponatremia, increased blood creatine phosphokinase, hypokalemia, increased blood creatinine, increased AST, hypocalcemia, lymphopenia, leukopenia, and anemia.

Development timeline for Cotellic

Nov  1, 2022Approval FDA Approves Oral MEK Inhibitor Cobimetinib for Histiocytic Neoplasms, Research Led by Memorial Sloan Kettering Cancer Center
Nov 10, 2015Approval FDA Approves Cotellic (cobimetinib) for the Combination Treatment of Advanced Melanoma
Jul  1, 2015Exelixis Provides Update on Genentech’s Pending NDA for Cobimetinib
Feb 18, 2015FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma
Dec 14, 2014Genentech Submits NDA to FDA for Investigational Cobimetinib Used in Combination with Zelboraf (vemurafenib) in Advanced Melanoma

Further information

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