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Dabrafenib + trametinib

Dabrafenib plus trametinib is the BRAF-plus-MEK pill combination, approved for BRAF V600E lung cancer and, since 2022, for any solid tumour with that mutation.

In BRAF V600E NSCLC (~2% of adenocarcinomas): ORR 64% first line, median PFS ~10.8 months (BRF113928). Tumour-agnostic approval June 2022 for BRAF V600E solid tumours (excluding colorectal). Pyrexia is the characteristic toxicity. Encorafenib + binimetinib (PHAROS, 2023) is the alternative doublet.

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Dabrafenib
PubChem
Modality
Small-molecule kinase inhibitors (BRAF + MEK)
Mechanism
BRAF V600 inhibitor plus allosteric MEK1/2 inhibitor; vertical blockade prevents paradoxical MAPK reactivation.
Brand / code
Tafinlar + Mekinist
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). Both components are Part D; the paediatric oral suspensions are also Part D.

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. BRAF V600 mutation by an approved test.

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 TA396 · 2016SMC: accepted
Appraised for
Unresectable or metastatic BRAF V600-mutated melanoma
Notes
Adjuvant stage III melanoma: TA544 (2018). BRAF V600E NSCLC: TA898 (2023). Dabrafenib monotherapy: TA321 (2014). Paediatric BRAF-mutated glioma appraised 2024-25.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA396 · SMC advice: dabrafenib with trametinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2017BRAF V600E metastatic NSCLC
US2022BRAF V600E solid tumours, tumour-agnostic (age ≥6)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
115 studies20 recruiting91 Phase 212 Phase 3
Search “Dabrafenib” 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
Dabrafenib + trametinib
intervention: Dabrafenib
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend43 papers in the last 12 months-4% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Dabrafenib + trametinib" OR ABSTRACT:"Dabrafenib + trametinib" OR TITLE:"Tafinlar + Mekinist" OR ABSTRACT:"Tafinlar + Mekinist") 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 Dabrafenib + trametinib, not a curated reading list.

Connected

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