New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the Phase IV clinical trial report for Lenvatinib Capsules 4 mg and 10 mg submitted by Eisai Pharmaceuticals India Private Limited, following a detailed review of safety data.
This came after the firm presented Serious Adverse Events reported during the Phase IV CT study along with its assessment reports before the committee.
The matter was taken up by the committee in light of its earlier recommendation dated 17 June 2025, pursuant to which the firm was required to place additional safety information on record.
Lenvatinib is a receptor tyrosine kinase inhibitor used for the treatment of metastatic thyroid cancer, advanced renal cell carcinoma in combination with everolimus, and unresectable hepatocellular carcinoma.
Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
At the recent SEC meeting, Eisai presented details of Serious Adverse Events (SAEs) reported during the conduct of the Phase IV clinical trial.
After detailed deliberation, the committee recommended to accept the Phase IV CT study report of Lenvatinib Capsules 4mg and 10 mg.