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Best Supportive Care (BSC)
Best Supportive Care (BSC) is a Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 3 development.
Best Supportive Care (BSC) is a control or comparator arm in clinical trials that provides standard medical management and symptom relief without the investigational drug.
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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). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC 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 | 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 | Best Supportive Care (BSC) |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
BSC is not a drug but rather a clinical trial design element representing the standard of care baseline. It typically includes symptom management, palliative measures, and conventional treatments available to patients in the control group, allowing researchers to measure the incremental benefit of the investigational therapy against established clinical practice.
Approved indications
Common side effects
Key clinical trials
- A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia (PHASE2)
- Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant (PHASE3)
- Phase II Study of Regorafenib as Maintenance Therapy (PHASE2)
- Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma (PHASE2)
- Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer
- Local Treatment Strategies for Brain Metastases of Colorectal Cancer
- Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma (PHASE2)
- A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS) (PHASE2, 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:
- Best Supportive Care (BSC) CI brief — competitive landscape report
- Best Supportive Care (BSC) updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Best Supportive Care (BSC)
What is Best Supportive Care (BSC)?
How does Best Supportive Care (BSC) work?
Who makes Best Supportive Care (BSC)?
What development phase is Best Supportive Care (BSC) in?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing