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Drug updated on 5/17/2024

Dosage FormTablet (oral; 20 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies


  • Indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
  • Indicated for the treatment of adult patients with histiocytic neoplasms, as a single agent.

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  • Cobimetinib (Cotellic) is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. It is also used as a single agent to treat adult patients with histiocytic neoplasms.
  • Ten studies were reviewed, comparing Cotellic (cobimetinib) in combination with other drugs versus various treatment regimens for BRAF V600-mutant unresectable or metastatic melanoma, focusing on safety and efficacy.
  • The effectiveness comparison indicates that cobimetinib combined with vemurafenib has a less favorable profile when compared to encorafenib + binimetinib due to superior overall response rates and fewer serious adverse events reported by the latter.
  • In terms of safety profile, cobimetinib + vemurafenib displays competitive safety but is outperformed by dabrafenib + trametinib, which showed fewer high-grade adverse events according to certain analyses.
  • Subgroup considerations reveal prognostic factors such as baseline lactate dehydrogenase, disease stage, performance status at progression, and initial post-progression treatment are significant for post-progression survival, emphasizing tailored treatments based on patient-specific factors.
  • Strategic sequencing of immunotherapy or targeted therapy significantly impacts survival outcomes, suggesting benefits of strategic treatment sequencing for advanced melanoma patients.

Product Monograph / Prescribing Information

Document TitleYearSource
Cotellic (cobimetinib) Prescribing Information.2023Genentech USA, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy and safety of targeted therapies for BRAF-mutant unresectable or metastatic melanoma: Results from a systematic literature review and a network meta-analysis2022Cancer treatment reviews
Acceptability of Drugs in the Treatment of Unresectable/Metastatic BRAF V600-Mutant Melanoma: A Systematic Review and Network Meta-Analysis2022Frontiers in oncology
Comparative efficacy of dabrafenib + trametinib versus treatment options for metastatic melanoma in first-line settings.2021Journal of Comparative Effectiveness Research
Efficacy and safety of dabrafenib-trametinib in the treatment of unresectable or metastatic melanoma with BRAF V600 mutation: a systematic review and network meta-analysis.2020Dermatologic therapy
Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials.2020Journal of translational medicine
Network indirect comparison of 3 BRAF + MEK inhibitors for the treatment of advanced BRAF mutated melanoma.2020Clinical & translational oncology
Efficacy and safety of dabrafenib–trametinib in the treatment of unresectable advanced/metastatic melanoma with BRAF-V600 mutation: a systematic review and network meta-analysis.2019Dermatologic Therapy
A systematic literature review and network meta-analysis of effectiveness and safety outcomes in advanced melanoma.2019European Journal of Cancer
Efficacy and adverse events in metastatic melanoma patients treated with combination braf plus mek inhibitors versus braf inhibitors: a systematic review.2019Cancers (Basel)
Comparative efficacy of combination immunotherapy and targeted therapy in the treatment of BRAF-mutant advanced melanoma: a matching-adjusted indirect comparison.2019Immunotherapy

Clinical Practice Guidelines