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US-Keytruda®
US-Keytruda is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses.
US-Keytruda is a PD-1 inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses. Used for Metastatic melanoma, Non-small cell lung cancer, Head and neck squamous cell carcinoma.
At a glance
| Generic name | US-Keytruda® |
|---|---|
| Also known as | Pembrolizumab Injection |
| Sponsor | Bio-Thera Solutions |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the PD-1 checkpoint, the drug prevents tumor cells from suppressing T cell activity. This allows the immune system to recognize and attack cancer cells more effectively. The mechanism is similar to other PD-1 inhibitors used in immuno-oncology.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Decreased appetite
- Immune-related pneumonitis
- Immune-related hepatitis
- Immune-related colitis
Key clinical trials
- A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) (PHASE3)
- A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors (PHASE1)
- A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma (PHASE1)
- A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer (PHASE3)
- A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants (PHASE1)
- A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (PHASE3)
- Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (PHASE1)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (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:
- US-Keytruda® CI brief — competitive landscape report
- US-Keytruda® updates RSS · CI watch RSS
- Bio-Thera Solutions portfolio CI