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Pembrolizumab Dose A
Pembrolizumab Dose A is a Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development. Also known as: KEYTRUDA®, MK-3475.
Pembrolizumab is used to treat various conditions, including Metastatic Melanoma, Non-Small Cell Lung Cancer, Melanoma, Metastatic Urothelial Carcinoma, and Locally Advanced Urothelial Carcinoma. However, there is no information provided about a "Dose A" of Pembrolizumab, suggesting that the term may be incorrect or not applicable.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme 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 | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Pembrolizumab Dose A |
|---|---|
| Also known as | KEYTRUDA®, MK-3475 |
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) (PHASE1)
- Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC (PHASE2)
- Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer (PHASE3)
- Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast 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:
- Pembrolizumab Dose A CI brief — competitive landscape report
- Pembrolizumab Dose A updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Pembrolizumab Dose A
What is Pembrolizumab Dose A?
Who makes Pembrolizumab Dose A?
Is Pembrolizumab Dose A also known as anything else?
What development phase is Pembrolizumab Dose A in?
Related
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Also known as: KEYTRUDA®, MK-3475
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing