Last reviewed 2026-06-03 · How we verify

Tunlametinib plus Vemurafenib

Shanghai Kechow Pharma, Inc. · Phase 3 active Small molecule Under review

Tunlametinib plus Vemurafenib is a BRAF inhibitor + MEK inhibitor combination Small molecule drug developed by Shanghai Kechow Pharma, Inc.. It is currently in Phase 3 development for BRAF V600E-mutant melanoma, BRAF V600E-mutant non-small cell lung cancer, BRAF V600E-mutant colorectal cancer.

This combination blocks BRAF and MEK signaling in the MAPK pathway to inhibit growth of BRAF-mutant melanoma and other cancers.

Tunlametinib plus Vemurafenib is being studied in a Phase 3 clinical trial for its efficacy and safety in patients with BRAF V600E-mutant metastatic colorectal cancer. Vemurafenib is a small molecule inhibitor of the serine/threonine-protein kinase B-raf.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Tunlametinib plus Vemurafenib
Sponsor	Shanghai Kechow Pharma, Inc.
Drug class	BRAF inhibitor + MEK inhibitor combination
Target	BRAF V600E and MEK1/2
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Vemurafenib is a BRAF V600E inhibitor that directly targets mutated BRAF kinase, while trametinib (tunlametinib) is a MEK1/2 inhibitor that blocks downstream signaling. Together, they provide dual inhibition of the MAPK pathway to overcome resistance and improve efficacy in BRAF-mutant tumors.

Approved indications

BRAF V600E-mutant melanoma
BRAF V600E-mutant non-small cell lung cancer
BRAF V600E-mutant colorectal cancer

Common side effects

Rash
Diarrhea
Nausea
Fatigue
Arthralgia
Pyrexia

Key clinical trials

Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Tunlametinib plus Vemurafenib CI brief — competitive landscape report
Tunlametinib plus Vemurafenib updates RSS · CI watch RSS
Shanghai Kechow Pharma, Inc. portfolio CI

Frequently asked questions about Tunlametinib plus Vemurafenib

What is Tunlametinib plus Vemurafenib?

Tunlametinib plus Vemurafenib is a BRAF inhibitor + MEK inhibitor combination drug developed by Shanghai Kechow Pharma, Inc., indicated for BRAF V600E-mutant melanoma, BRAF V600E-mutant non-small cell lung cancer, BRAF V600E-mutant colorectal cancer.

How does Tunlametinib plus Vemurafenib work?

This combination blocks BRAF and MEK signaling in the MAPK pathway to inhibit growth of BRAF-mutant melanoma and other cancers.

What is Tunlametinib plus Vemurafenib used for?

Tunlametinib plus Vemurafenib is indicated for BRAF V600E-mutant melanoma, BRAF V600E-mutant non-small cell lung cancer, BRAF V600E-mutant colorectal cancer.

Who makes Tunlametinib plus Vemurafenib?

Tunlametinib plus Vemurafenib is developed by Shanghai Kechow Pharma, Inc. (see full Shanghai Kechow Pharma, Inc. pipeline at /company/shanghai-kechow-pharma-inc).

What drug class is Tunlametinib plus Vemurafenib in?

Tunlametinib plus Vemurafenib belongs to the BRAF inhibitor + MEK inhibitor combination class. See all BRAF inhibitor + MEK inhibitor combination drugs at /class/braf-inhibitor-mek-inhibitor-combination.

What development phase is Tunlametinib plus Vemurafenib in?

Tunlametinib plus Vemurafenib is in Phase 3.

What are the side effects of Tunlametinib plus Vemurafenib?

Common side effects of Tunlametinib plus Vemurafenib include Rash, Diarrhea, Nausea, Fatigue, Arthralgia, Pyrexia.

What does Tunlametinib plus Vemurafenib target?

Tunlametinib plus Vemurafenib targets BRAF V600E and MEK1/2 and is a BRAF inhibitor + MEK inhibitor combination.

Drug class: All BRAF inhibitor + MEK inhibitor combination drugs
Target: All drugs targeting BRAF V600E and MEK1/2
Manufacturer: Shanghai Kechow Pharma, Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for BRAF V600E-mutant melanoma
Indication: Drugs for BRAF V600E-mutant non-small cell lung cancer
Indication: Drugs for BRAF V600E-mutant colorectal cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing