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Treatment of Encorafenib & Binimetinib & Cetuximab (treatment-of-encorafenib-binimetinib-cetuximab)
Treatment of Encorafenib & Binimetinib & Cetuximab (generic name: treatment-of-encorafenib-binimetinib-cetuximab) is a Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4 Monoclonal antibody 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, Binimetinib, and Cetuximab are being studied in clinical trials for the treatment of BRAF V600E mutated or pMMR localized colorectal cancer. Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor, which works by blocking the activity of the EGFR protein.
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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 | treatment-of-encorafenib-binimetinib-cetuximab |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 4 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | preclinical |
Approved indications
Pipeline indications
- Solid Tumors — preclinical
Common side effects
Key clinical trials
- The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials (PHASE4)
- Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer (PHASE3)
- Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer (PHASE2)
- PF-07284892 in Participants With Advanced Solid Tumors (PHASE1)
- Study to Evaluate the Efficacy and Safety of Cetuximab in Combination with Encorafenib Plus Binimetinib As Induction Treatment in BRAF V600E Mutated MSS Initially Resectable or Potentially Resectable Advanced Colorectal Cancer (PHASE2)
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:
- Treatment of Encorafenib & Binimetinib & Cetuximab CI brief — competitive landscape report
- Treatment of Encorafenib & Binimetinib & Cetuximab updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Treatment of Encorafenib & Binimetinib & Cetuximab
What is Treatment of Encorafenib & Binimetinib & Cetuximab?
How does Treatment of Encorafenib & Binimetinib & Cetuximab work?
Who makes Treatment of Encorafenib & Binimetinib & Cetuximab?
What is the generic name of Treatment of Encorafenib & Binimetinib & Cetuximab?
What drug class is Treatment of Encorafenib & Binimetinib & Cetuximab in?
What development phase is Treatment of Encorafenib & Binimetinib & Cetuximab in?
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