English | 简体中文 | 繁體中文 | 한국어 | 日本語
Monday, 22 February 2021, 14:40 HKT/SGT
Share:
    

Source: Eisai
Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090
With Prospective Indication for Unresectable Biliary Tract Cancer with FGFR2 Gene Fusion

TOKYO, Feb 22, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, Japan (MHLW) for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor E7090, which is currently under development as an orally available novel anti-cancer agent.

FGFRs with genetic aberrations are known to play an important role in the proliferation, survival and migration of cancer cells as well as tumor angiogenesis and drug resistance. These genetic aberrations in FGFRs have been observed in various types of cancers, therefore, there is growing interest in FGFRs as a promising target for cancer therapy. By selectively inhibiting FGFR1, 2 and 3, and blocking those signals, E7090 has the potential to become a new molecular targeted therapy for cancers with FGFR genetic aberrations.

In Japan, a Phase I clinical trial of E7090 was conducted, and E7090 has been designated as the target drug for the SAKIGAKE Designation System of the MHLW for the treatment of unresectable biliary tract cancer. Currently, a Phase II clinical trial (Study 201) of E7090 is underway in patients with cholangiocarcinoma with FGFR2 gene fusion in Japan and China.

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of E7090 for cancer treatment, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer and their families.

1. About E7090

Discovered in-house by Eisai's Tsukuba Research Laboratories, E7090 is an orally available novel tyrosine kinase inhibitor that demonstrates selective inhibitory activity against fibroblast growth factor receptors (FGFR) FGFR1, FGFR2 and FGFR3. Distinct from prior known FGFR inhibitors, E7090 has a basic structure which lacks the dimethoxyphenyl moiety, and in a kinetic interaction analysis study, it was observed that E7090 demonstrates antitumor effects due to inhibition of kinase activity with a binding mode (Type V) that exhibits rapid and potent binding as well as high selectivity to FGFR.(1)

A Phase II clinical trial (Study 201) of E7090 is underway in Japan and China to evaluate efficacy and safety in patients with cholangiocarcinoma with FGFR2 gene fusion. A Phase I clinical trial of E7090 is also underway in Japan in patients with estrogen receptor-positive and HER2-negative breast cancer.

2. About Biliary Tract Cancer with FGFR2 Gene Fusion

The five-year survival rate for biliary tract cancer is approximately 20%, which makes it an intractable cancer with the second worst prognosis following pancreatic cancer.(2) Drug therapy options are limited in comparison with other cancers, and as such it is a disease with significant unmet medical needs. The estimated number of patients with biliary tract cancer is approximately 32,000 in Japan.(3),(4),(5) FGFR2 gene fusion is observed in approximately 14% of intrahepatic cholangiocarcinoma, which account for 15-30% of biliary tract cancers.(6)

3. Orphan Drug Designation System in Japan

The orphan drug designation system in Japan aims to support the development of drugs for diseases for which the number of patients is small and research and development is not progressing, despite high unmet medical need. As the requirement for designation based on Article 77-2 of the Pharmaceutical and Medical Device Act (PMD Act) of Japan, a drug must meet the following conditions in order to be considered for orphan drug designation in Japan: the number of people expected to use the drug for its intended use is less than 50,000 people in Japan; there is no suitable alternative drug or treatments in Japan, or the proposed drug is expected to be significantly more effective or safer than drugs already available on the Japanese market; and there is a scientific rationale to support the necessity of the drug for the target disease, and the development plan for the drug is appropriate. Specific measures to support the development of orphan drugs include giving prioritized consultation regarding clinical development and conducting priority examinations, reducing application fees, extending registration validity period, granting subsidies for research and development expenditures, and tax incentives.

(1) Watanabe Miyano S. et al., "E7090, a Novel Selective Inhibitor of Fibroblast Growth Factor Receptors, Displays Potent Antitumor Activity and Prolongs Survival in Preclinical Models", Molecular Cancer Therapeutics, 2016, 15(11), 2630-2639.
(2) Latest statistics, Cancer Information Service, National Cancer Center, Japan.
(3) Official Statics of Japan (e-Stat), 2017 Patient Survey https://www.e-stat.go.jp/(New Window)
(4) The 21st Follow-up Survey Reports for Primary Liver Cancer Cases in Japan (2010-2011), 2020.
(5) Shin Ishihara. et al., "Biliary tract cancer registry in Japan from 2008 to 2013", J Hepatobiliary Pancreat Sci., 2016, 23, 149-157.
(6) Arai Y. et al., "Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma", Hepatology, 2014, 59, 1427-1434.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120


Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2021 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Eisai Releated News
Feb 22, 2021 14:00 HKT/SGT
エーザイ、新規線維芽細胞増殖因子(FGF)受容体選択的チロシンキナーゼ阻害剤E7090が日本においてFGFR2融合遺伝子を有する切除不能な胆道がんを予定される効能・効果として厚生労働省より希少疾病用医薬品に指定
Feb 22, 2021 12:11 HKT/SGT
Eisai Receives Corporate Philanthropy Award for Its Efforts to Realize Human Health Care (hhc) Philosophy
Feb 22, 2021 09:00 HKT/SGT
エーザイ、ヒューマン・ヘルスケア理念実現に向けた取り組みについて「企業フィランソロピー大賞」を受賞
Feb 15, 2021 10:07 HKT/SGT
LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrated Superior Progression-Free Survival (PFS) and Overall Survival (OS) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
Feb 15, 2021 09:00 HKT/SGT
エーザイとMSD、「レンビマ(R)」と「キイトルーダ(R)」の併用療法が進行性腎細胞がんの一次治療として、対照薬のスニチニブに対して、無増悪生存期間および全生存期間の有意な改善を示す
More news >>
Copyright © 2021 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 400 879 3881 | Hong Kong: +852 8192 4922 | Singapore: +65 6653 1210 | Tokyo: +81 3 6859 8575