Shitara, Kohei http://orcid.org/0000-0001-5196-3630
Yamaguchi, Kensei
Muro, Kei
Yasui, Hisateru
Sakai, Daisuke
Oshima, Takashi
Fujimura, Masahiro
Sato, Yuta
Yamazaki, Shunsuke
Wakabayashi, Tatsuya
Sugihara, Masahiro
Kamio, Takahiro
Shoji, Hirokazu
Funding for this research was provided by:
Daiichi-Sankyo Co., Ltd.
Article History
Received: 16 May 2023
Accepted: 2 October 2023
First Online: 14 November 2023
Declarations
:
: Kohei Shitara has provided an advisory role to Ono Pharmaceutical Co., Ltd., Merck Ltd., Taiho Pharmaceutical Co., Ltd., Astellas Pharma Inc., Novartis Pharma K.K., AbbVie G.K., GlaxoSmithKline K.K., Daiichi Sankyo Co., Ltd., and Amgen K.K.; and has received honoraria from Takeda Pharmaceutical Co., Ltd., Bristol-Myers Squibb K.K., and Janssen Pharmaceutical K.K.; and has received research funding from Astellas Pharma Inc., Ono Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Merck Ltd., Mediscience Planning, Inc., Eisai Co., Ltd., and Amgen K.K. Kensei Yamaguchi has provided an advisory role to and has received honoraria from Daiichi Sankyo Co., Ltd. Kei Muro has received lecture fees from Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Bristol-Myers Squibb K.K.; and has received research funding from Sanofi K.K., Eisai Co., Ltd., Astellas Pharma Inc., Amgen K.K., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Taiho Pharmaceutical Co., Ltd., MSD K.K., Ono Pharmaceutical Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Hisateru Yasui has received honoraria and research funding from Daiichi Sankyo Co., Ltd. Daisuke Sakai has received honoraria from Daiichi Sankyo Co., Ltd.; and has received research funding from Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. Takashi Oshima has no conflicts to declare. Masahiro Fujimura, Yuta Sato, Shunsuke Yamazaki, Tatsuya Wakabayashi, and Masahiro Sugihara are employees of Daiichi Sankyo Co., Ltd. Takahiro Kamio is an employee of Daiichi Sankyo, Inc. Hirokazu Shoji has received research funding from Ono Pharmaceutical Co., Ltd., MSD K.K., Amgen K.K., and Takeda Pharmaceutical Co., Ltd.
: This expanded-access study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and Good Clinical Practice guidelines, the Pharmaceuticals and Medical Devices Act (November 25, 2014), and the Japan Ministry of Health and Welfare Ordinance no. 28 on Standards for Conduct of Clinical Trials (March 27, 1997). Patients were informed about the purpose of the expanded-access study, and written informed consent was obtained.