Daiichi Sankyo submits NDA in Japan for Gilead's CAR-T drug

31 March 2020

A New Drug Application (NDA) has been submitted to Japan’s Ministry of Health, Labor and Welfare for the CAR-T therapy axicabtagene ciloleucel to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and related lymphomas.

This drug was developed by Kite Pharma, a subsidiary of US biotech Gilead Sciences (Nasdaq: GILD), and has been approved in western markets under the brand name Yescarta.

In January 2017, Japanese drugmaker Daiichi Sankyo (TYO: 4568) agreed to acquire exclusive development, manufacturing and commercialization rights for the product in Japan.

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