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Phase 3 clinical data showed that the K+L combination demonstrated statistically significant improvements in multiple efficacy endpoints compared to sunitinib
Eisai recently announced that the combination regimen of Lenvima (Levima, generic name: lenvatinib, lenvatinib) and Keytruda (Keytruda, generic name: pembrolizumab, pembrolizumab) has been approved in Taiwan, China Approved: For first-line treatment of patients with advanced renal cell carcinoma (RCC)
Lenvima + Keytruda, a "targeted + immune" combination therapy, has been approved by US and EU regulators in August and November 2021, respectively, for the first-line treatment of adult patients with advanced RCC
The approval is based on data from the pivotal Phase 3 clinical trial CLEAR (Study 307/KEYNOTE-581)
It is estimated that in 2020, there will be more than 430,000 newly diagnosed cases of kidney cancer worldwide and more than 180,000 deaths
The Lenvima+Keytruda combination therapy is part of a strategic collaboration between Eisai and Merck Oncology
Keytruda is an anti-PD-1 tumor immunotherapy that helps detect and fight tumor cells by boosting the body's immune system's ability
Lenvima is an oral multi-receptor tyrosine kinase (RTK) inhibitor with a novel binding mode, in addition to inhibiting other pro-angiogenic and oncogenic signaling pathway-related RTKs involved in tumor angiogenesis, tumor progression, and tumor immune modification (including In addition to platelet-derived growth factor (PDGF) receptors PDGFRα, KIT and RET), it also selectively inhibits vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4) kinase activity
Currently, Eisai and Merck are conducting LEAP (LEnvatinib and Pembrolizumab) clinical development programs in more than 10 different tumor types (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma) The Lenvima+Keytruda combination continues to be studied in more than 20 clinical trials in squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer, and triple-negative breast cancer
