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Encorafenib & Binimetinib Treatment (encorafenib-binimetinib-treatment)
Encorafenib & Binimetinib Treatment (generic name: encorafenib-binimetinib-treatment) is a Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4 drug developed by Pfizer Inc.. It is currently in preclinical development.
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4
Encorafenib and Binimetinib are used to treat various types of melanoma, including Acral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain, and Metastatic Melanoma. Binimetinib works as a dual specificity mitogen-activated protein kinase kinase 1 inhibitor, a small molecule that targets the same molecular pathway.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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 | encorafenib-binimetinib-treatment |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4 |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Cancer cells often depend on a chain of molecular communications to survive and grow. In melanoma with a BRAF mutation, cancer cells have a broken switch that gets stuck in the "on" position, continuously telling the cell to divide. Encorafenib directly targets and blocks BRAF, the faulty protein at the beginning of this chain. However, cancer cells are clever—they sometimes find a detour around this single block by activating the next protein in line, called MEK. By combining encorafenib with binimetinib, doctors block both BRAF and MEK simultaneously. Think of it like closing two consecutive doors on an escape route instead of just one. When the first door (BRAF) is blocked, cancer cells cannot use the second door (MEK) to work around the treatment. This two-pronged approach is more effective because it prevents the most common way cancer cells develop resistance to single-drug treatment. When both proteins are blocked, the cancer cells lose their ability to receive growth signals. Without these instructions to divide and survive, the cells stop multiplying and eventually die. This combination has proven more effective than using either drug alone, giving patients better outcomes and longer survival.
Approved indications
Pipeline indications
- Solid Tumors — preclinical
Common side effects
Key clinical trials
- Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG (Phase 2)
- The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib fo (Phase 4)
- An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lun (Phase 2)
- A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients (Phase 3)
- Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patient (Phase 1)
- Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- (Phase 3)
- LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced B (Phase 2)
- Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal (Phase 2)
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:
- Encorafenib & Binimetinib Treatment CI brief — competitive landscape report
- Encorafenib & Binimetinib Treatment updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Encorafenib & Binimetinib Treatment
What is Encorafenib & Binimetinib Treatment?
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Who makes Encorafenib & Binimetinib Treatment?
What is the generic name of Encorafenib & Binimetinib Treatment?
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Related
- Drug class: All Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4 drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing