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drugsProductApproved2015🇪🇺🇬🇧🇯🇵🇦🇺

Cobimetinib

Cobimetinib is the MEK partner for vemurafenib, and the first drug approved for histiocytic neoplasms.

coBRIM (2015): PFS 12.3 vs 7.2 months added to vemurafenib in BRAF V600 melanoma. Also approved with atezolizumab and vemurafenib (IMspire150, 2020) and alone for histiocytic neoplasms (2022). Retinopathy, photosensitivity, CK elevation.

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Cobimetinib
PubChem
Mechanism, step by step
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1.Binds MEK1/2 allosterically

Modality
Small-molecule kinase inhibitor (MEK1/2)
Mechanism
Allosteric MEK1/2 inhibitor.
Brand / code
Cotellic
Dosing & schedule
Route
Oral
Schedule
60 mg once daily for 21 days of each 28-day cycle, with vemurafenib

Source: www.accessdata.fda.gov/drugsatfda_docs/label/2022/206192s006lbl.pdf. Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Assistance programmes

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA414 · 2016SMC: accepted
Appraised for
With vemurafenib for BRAF V600 mutation-positive melanoma
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA414 · SMC advice: cobimetinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2015BRAF V600 melanoma with vemurafenib
US2020With atezolizumab and vemurafenib in BRAF V600 melanoma
US2022Histiocytic neoplasms

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
79 studies14 recruiting72 Phase 210 Phase 3
Search “Cobimetinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Cobimetinib
intervention: Cobimetinib
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend50 papers in the last 12 months+2% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Cobimetinib" OR ABSTRACT:"Cobimetinib" OR TITLE:"Cotellic" OR ABSTRACT:"Cotellic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Cobimetinib, not a curated reading list.

Connected

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