Lenvatinib

Eisai to Present Abstracts on Lenvatinib at 2021 Gastrointestinal Cancers Symposium

Tuesday, January 12, 2021 - 3:37am

TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.

Key Points: 
  • TOKYO, Jan 12, 2021 - (JCN Newswire) - Eisai Co., Ltd. has announced that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib") will be given at the Gastrointestinal Cancers Symposium Virtual Meeting, from January 15 to 17, 2021.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these Ricchi, with the aim of contributing to the cure of cancers.

Eisai to Present Abstracts on Oncology Products and Pipeline at 43rd Annual San Antonio Breast Cancer Symposium

Friday, December 4, 2020 - 3:17am

The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.

Key Points: 
  • The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

Eisai: Application for Additional Indication of Anti Cancer Agent Lenvima for Unresectable Thymic Carcinoma Submitted in Japan

Friday, July 31, 2020 - 1:31am

a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate).

Key Points: 
  • a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate).
  • In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.
  • This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.
  • This study met its endpoint as the lower value of the CI exceeded the pre-specified statistical criteria, a threshold ORR of 10%.

Eisai and Merck Receive Complete Response Letter for LENVIMA (lenvatinib) plus KEYTRUDA (pembrolizumab) Combination as First-Line Treatment for Unresectable Hepatocellular Carcinoma

Thursday, July 9, 2020 - 4:11am

The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting.

Key Points: 
  • The applications were based on data from the Phase 1b Study 116/KEYNOTE-524 trial, which showed clinically meaningful efficacy in the single-arm setting.
  • Ahead of the PDUFA action dates of Eisai's and Merck's applications, another combination therapy was approved based on a randomized controlled trial that demonstrated overall survival.
  • As such, LEAP-002, the Phase 3 trial evaluating the LENVIMA plus KEYTRUDA combination as a first-line treatment for advanced HCC, is currently underway and fully enrolled.
  • Eisai and Merck are continuing to evaluate the LENVIMA plus KEYTRUDA combination across 13 different tumor types in 18 clinical trials including the LEAP (LEnvatinib And Pembrolizumab) clinical program.

Eisai to Present Data on Oncology Pipeline and Products at ASCO20 Annual Meeting

Thursday, May 14, 2020 - 1:22am

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Key Points: 
  • In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
  • Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer.
  • There is no guarantee that any investigational compounds and investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • For more information about Eisai Co., Ltd., please visit https://www.eisai.com

Eisai to Present Latest Data on LENVIMA® (lenvatinib) at the 2020 Gastrointestinal Cancers Symposium

Tuesday, January 21, 2020 - 10:27pm

WOODCLIFF LAKE, N.J., Jan. 21, 2020 /PRNewswire/ --Eisai announced today the presentation of three abstracts at the 2020 Gastrointestinal Cancers Symposium (#GI20) in San Francisco from January 23-25.

Key Points: 
  • WOODCLIFF LAKE, N.J., Jan. 21, 2020 /PRNewswire/ --Eisai announced today the presentation of three abstracts at the 2020 Gastrointestinal Cancers Symposium (#GI20) in San Francisco from January 23-25.
  • Across clinical trials in 799 patients with DTC, RCC, and HCC, grade 3 or higher cardiac dysfunction occurred in 3% of LENVIMA treated patients.
  • Fistula Formation and Gastrointestinal Perforation.Of the 799 patients treated with LENVIMA or LENVIMA + everolimus in DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred in 2%.
  • LENVIMA is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
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International collaboration among Canadian, U.S. and Australian regulators leads to new options for the treatment of cancer

Friday, December 6, 2019 - 3:28pm

On September 20, 2019, Health Canada authorized a new treatment for women who haveadvanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab).

Key Points: 
  • On September 20, 2019, Health Canada authorized a new treatment for women who haveadvanced endometrial cancer through the combined use of Lenvima (lenvatinib) and Keytruda (pembrolizumab).
  • This was the first review conducted under Project Orbis , an initiative of the U.S.Food and Drug Administration (FDA) Oncology Center of Excellence.
  • Project Orbis brings together regulators from multiple countries to review cancer drugs at the same time so that patients can receive earlier access to needed treatments.
  • Between July and November 2019, Health Canada authorized 20 new drugs and medical devices to treat a range of health issues.

Eisai Announces Data at ASCO 2018 Annual Meeting Showcasing LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) Combination Therapy Under Strategic Oncology Collaboration with Merck

Thursday, May 17, 2018 - 1:08pm

In RCC, hypertension was reported in 42% of patients on LENVIMA + everolimus vs 10% with everolimus alone (13% vs 2% grade 3).

Key Points: 
  • In RCC, hypertension was reported in 42% of patients on LENVIMA + everolimus vs 10% with everolimus alone (13% vs 2% grade 3).
  • Withhold dose for grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose when controlled at grade 2.
  • In RCC, arterial thromboembolic events were reported in 2% of patients on LENVIMA + everolimus vs 6% with everolimus alone (2% vs 4% grade 3).
  • In March 2018, Eisai and Merck, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA (lenvatinib).