Tags : Lenvima

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II

Shots: The P-II 218 study involves assessing Lenvima (14mg, qd) + everolimus (5mg, qd) vs Lenvima (18mg, qd) + everolimus (5mg qd) in patients with clear-cell RCC, following treatment with an anti-angiogenic therapy, with prior anti-PD-1/PD-L1 therapy permitted In the primary analysis, @24wks. ORR (32.1% vs 34.8%) i.e. lower dose did not meet the threshold […]Read More

Merck’s Keytruda (pembrolizumab) + Eisai’s Lenvima (lenvatinib) Receives FDA’s Approval

Shots: The approval is based on P-II KEYNOTE-146/Study 111 assessing Keytruda (200mg, IV, q3w) + Lenvima (20mg, PO, qd) in 108 patients with metastatic endometrial carcinoma that is not microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) with diseases progression following prior systemic therapy and are not candidates for curative surgery or radiation The P-II KEYNOTE-146/Study 111 […]Read More

Merck and Eisai’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive FDA’s

Shots: The third BT designation is based on P-Ib KEYNOTE-524 study assessing Keytruda (200mg, IV, q3w) + Lenvima (12/8 mg/day) in patients with unresectable HCC not amenable to locoregional treatment The dual regimen has received its first two BT designation for advanced and metastatic renal carcinoma and non-microsatellite instability-high/proficient mismatch repair endometrial carcinoma in Jan’18 […]Read More

Eisai and Merck Annouces the US FDA Approval of Lenvima

Shots: Approval is based on positive results of Ph III REFLECT study showing improved OS, PFS and ORR REFLECT results (Lenvima vs Sorafenib): mOS (13.6 vs 12.3 mos), mPFS (7.3 vs 3.6 mos); ORR (41% vs 12%) with AE ≥20% patients & SAEs ≥2%   Lenvima has been approved in Japan in H1’18 for HCC […]Read More