Tag Archives: lenvima

November, 2018

9 November
New Data Support Ongoing Clinical Program for Lenvima and Keytruda Combination Across Multiple Tumor Types

TOKYO & KENILWORTH, N.J.–(BUSINESS WIRE)–Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 …
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17 August
FDA Approves Lenvima Capsules for First-Line Treatment of Unresectable Hepatocellular Carcinoma

TOKYO August 17, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the …
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2 August
FDA Grants Breakthrough Therapy Designation to Lenvima in Combination with Keytruda for Endometrial Carcinoma

TOKYO & KENILWORTH, N.J.–(BUSINESS WIRE)–Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA® (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) …
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9 January
FDA Grants Breakthrough Therapy Designation to Eisai and Merck’s Kidney Cancer Combo Therapy

TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) …
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27 September
FDA Accepts sNDA for Eisai’s Lenvatinib for the Treatment of Hepatocellular Carcinoma

WOODCLIFF LAKE, N.J., Sept. 26, 2017 /PRNewswire/ — Eisai Inc. today announced the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (marketed as Lenvima®) for the potential use in the first-line treatment of patients with hepatocellular carcinoma (HCC), commonly referred to as liver cancer. …
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25 January
Eisai’s Lenvatinib Meets Primary Endpoint in Late-Stage Hepatocellular Carcinoma Study

WOODCLIFF LAKE, N.J., Jan. 25, 2017 /PRNewswire/ — Eisai Inc. today announced positive topline results from the randomized, multicenter Phase 3 trial (Study 304) evaluating the company’s multiple receptor tyrosine kinase inhibitor, lenvatinib (marketed as Lenvima®), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The trial achieved …
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13 February
Eisai’s Thyroid Cancer Drug Receives Early FDA Approval

The US Food and Drug Administration (FDA) has granted an early approval to Eisai’s drug for the most common form of thyroid cancer. The agency announced that it has approved the Japanese drugmaker’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive …
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