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Placebo matching lenvatinib
Lenvatinib is a multi-targeted tyrosine kinase inhibitor that blocks signaling pathways critical for tumor growth and angiogenesis.
Lenvatinib is a multi-targeted tyrosine kinase inhibitor that blocks signaling pathways critical for tumor growth and angiogenesis. Used for Radioiodine-refractory differentiated thyroid cancer, Unresectable hepatocellular carcinoma, Advanced renal cell carcinoma (in combination with pembrolizumab).
At a glance
| Generic name | Placebo matching lenvatinib |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Multi-targeted tyrosine kinase inhibitor |
| Target | FGFR, VEGFR, RET, KIT |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lenvatinib inhibits multiple receptor tyrosine kinases including FGFR, VEGFR, RET, and KIT, thereby suppressing tumor cell proliferation, survival, and the formation of new blood vessels that feed tumors. By targeting these pathways simultaneously, it provides broad anti-cancer activity across multiple tumor types. This placebo-matching formulation is used in clinical trials to maintain blinding while delivering the active lenvatinib dose.
Approved indications
- Radioiodine-refractory differentiated thyroid cancer
- Unresectable hepatocellular carcinoma
- Advanced renal cell carcinoma (in combination with pembrolizumab)
- Endometrial carcinoma (in combination with pembrolizumab)
Common side effects
- Hypertension
- Diarrhea
- Fatigue
- Decreased appetite
- Nausea
- Vomiting
- Weight loss
- Proteinuria
- Palmar-plantar erythrodysesthesia
Key clinical trials
- A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010) (PHASE3)
- A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension (PHASE3)
- Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006) (PHASE3)
- Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) (PHASE3)
- Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study (PHASE3)
- A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval (PHASE1)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) (PHASE3)
- A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China (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:
- Placebo matching lenvatinib CI brief — competitive landscape report
- Placebo matching lenvatinib updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI