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Encorafenib only Treatment (encorafenib-only-treatment)
Encorafenib only Treatment (generic name: encorafenib-only-treatment) is a Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent drug developed by Pfizer Inc.. It is currently in preclinical development.
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent
Encorafenib is a BRAF inhibitor that blocks a specific cancer-causing protein mutation found in melanoma and other cancers. It works by targeting cells with the BRAF V600E/K mutation, preventing them from growing and dividing. This targeted approach allows for more precise treatment with potentially fewer side effects compared to traditional chemotherapy.
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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-only-treatment |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Cancer cells sometimes develop a mutation in a gene called BRAF that causes the protein it produces to become permanently stuck in the "on" position. This mutated BRAF protein continuously sends growth signals to the cancer cell, telling it to divide and spread without stopping. Encorafenib is designed to fit into and block this mutated BRAF protein, essentially turning off the faulty growth signal that drives the cancer. By blocking the mutated BRAF protein, encorafenib prevents cancer cells from receiving the signals they need to survive and multiply. This selective targeting means the drug primarily affects cancer cells that carry this specific mutation while generally sparing normal cells that don't have the problem. The result is that tumors stop growing and often begin to shrink as the cancer cells either die or stop dividing. This approach represents a shift toward personalized medicine in cancer treatment—rather than using drugs that poison all rapidly dividing cells indiscriminately, encorafenib targets a specific molecular defect found in certain cancers. This precision typically means patients may experience different side effects than with traditional chemotherapy, and treatment can be more effective for those whose tumors have the BRAF mutation.
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 fo (Phase 4)
- LGX818 for Patients With BRAFV600 Mutated Tumors (Phase 2)
- 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)
- A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations (Phase 1)
- 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)
- A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Al (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 only Treatment CI brief — competitive landscape report
- Encorafenib only Treatment updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Encorafenib only Treatment
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Related
- Drug class: All Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing