Regulatory Affairs

Daiichi Sankyo’s DS-8201 gets SAKIGAKE designation in Japan for gastric cancer

Published 28 March 2018

The Japan Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE Designation to Daiichi Sankyo’s investigational HER2-targeting antibody drug conjugate (ADC) DS-8201 for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer.

Daiichi Sankyo R&D Division Oncology Function head, executive officer Koichi Akahane said: "There are no HER2-targeting treatment options currently available for patients with HER2-positive gastric cancer whose tumors are no longer controlled by trastuzumab.

"We look forward to working closely with the Japan Ministry of Health, Labour and Welfare under the terms of the SAKIGAKE program to accelerate the development of DS-8201 particularly since Japan has one of the highest incidence rates of gastric cancer worldwide."

The SAKIGAKE Designation System promotes R&D in Japan, driving early practical application for innovative pharmaceutical products, medical devices and regenerative medicines.

As a designated medicine under the SAKIGAKE Designation system, DS-8201 will have prioritized consultation, a dedicated review system to support the development and review process, as well as reduced review time from the normal 12 to 6 months.

Daiichi Sankyo oncology research and development executive vice president and global head Antoine Yver said: "We are pleased that DS-8201 has received SAKIGAKE Designation for advanced HER2-positive gastric cancer, which follows the Breakthrough Therapy and Fast Track designations granted by the U.S. FDA for HER2-positive metastatic breast cancer.

"These three designations for DS-8201 underscore our commitment to active and close collaborations with health authorities in order to potentially bring DS-8201 as a new treatment option to patients with different types of HER2-expressing cancers worldwide as quickly as possible."

SAKIGAKE Designation was granted based on the results of an ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201.

Updated preliminary results of DS-8201 from a subgroup analysis of HER2-positive advanced gastric cancer previously treated with trastuzumab and chemotherapy were recently presented at the 2018 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.

Source: Company Press Release