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Anti-B-RAF
Anti-B-RAF is a B-Raf inhibitor Small molecule drug developed by Istituto Oncologico Veneto IRCCS. It is currently in Phase 2 development for Metastatic melanoma with a V600E mutation, Other cancers with B-Raf mutations.
Anti-B-RAF drugs target and inhibit the B-Raf protein, which is often mutated in cancer cells.
Anti-B-RAF drugs target and inhibit the B-Raf protein, which is often mutated in cancer cells. Used for Metastatic melanoma with a V600E mutation, Other cancers with B-Raf mutations.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Anti-B-RAF |
|---|---|
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Drug class | B-Raf inhibitor |
| Target | B-Raf |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
The B-Raf protein is a kinase that plays a key role in cell signaling pathways. Mutations in this protein can lead to uncontrolled cell growth and cancer. By inhibiting B-Raf, these drugs aim to slow or stop the growth of cancer cells.
Approved indications
- Metastatic melanoma with a V600E mutation
- Other cancers with B-Raf mutations
Common side effects
- Hypertension
- Fatigue
- Dermatitis
- Diarrhea
- Rash
Key clinical trials
- Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia (PHASE1, PHASE2)
- Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (PHASE1, PHASE2)
- PF-07284892 in Participants With Advanced Solid Tumors (PHASE1)
- Phase I Study of the BBP-398 in Patients With Advance Solid Tumors (PHASE1)
- Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy (PHASE2)
- Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer (PHASE2)
- Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors
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:
- Anti-B-RAF CI brief — competitive landscape report
- Anti-B-RAF updates RSS · CI watch RSS
- Istituto Oncologico Veneto IRCCS portfolio CI
Frequently asked questions about Anti-B-RAF
What is Anti-B-RAF?
How does Anti-B-RAF work?
What is Anti-B-RAF used for?
Who makes Anti-B-RAF?
What drug class is Anti-B-RAF in?
What development phase is Anti-B-RAF in?
What are the side effects of Anti-B-RAF?
What does Anti-B-RAF target?
Related
- Drug class: All B-Raf inhibitor drugs
- Target: All drugs targeting B-Raf
- Manufacturer: Istituto Oncologico Veneto IRCCS — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma with a V600E mutation
- Indication: Drugs for Other cancers with B-Raf mutations
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing