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Cotellic (cobimetinib)

Roche · FDA-approved active Quality 66/100

Cotellic works by blocking the activity of two proteins, BRAF and MEK, which are involved in the growth and spread of cancer cells.

Cobimetinib (Cotellic), marketed by Roche, is approved for the treatment of unresectable or metastatic melanoma, competing in a crowded MEK inhibitor market. A key strength of Cotellic is its dual mechanism of action, inhibiting both BRAF and MEK, which may offer a more comprehensive approach to managing cancer cell growth and spread. The primary risk is the strong competition from other same-class drugs, such as trametinib, binimetinib, and selumetinib, all of which have later patent expiries, potentially eroding Cotellic's market share over time.

At a glance

Generic namecobimetinib
SponsorRoche
Drug classKinase Inhibitor
TargetDual specificity mitogen-activated protein kinase kinase 1
Therapeutic areaOncology
PhaseFDA-approved
First approval2015
Annual revenue200

Mechanism of action

Cobimetinib is reversible inhibitor of mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase (MEK1) and MEK2. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF V600E and mutations result in constitutive activation of the BRAF pathway which includes MEK1 and MEK2. In mice implanted with tumor cell lines expressing BRAF V600E, cobimetinib inhibited tumor cell growth.Cobimetinib and vemurafenib target two different kinases in the RAS/RAF/MEK/ERK pathway. Compared to either drug alone, coadministration of cobimetinib and vemurafenib resulted in increased apoptosis in vitro and reduced tumor growth in mouse implantation models of tumor cell lines harboring BRAF V600E mutations. Cobimetinib also prevented vemurafenib-mediated growth enhancement of wild-type BRAF tumor cell line in an in vivo mouse implantation model.

Approved indications

Common side effects

Key clinical trials

Patents

PatentExpiryType

Primary sources

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SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results
FDA Orange BookPatents + exclusivity
SEC EDGARRevenue + earnings

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