BASEL (dpa-AFX) - Novartis (NVS) said that it has received marketing authorization from Japan for Foundation for Biomedical Research and Innovation at Kobe or 'FBRI' to manufacture and supply commercial Kymriah or tisagenlecleucel for patients in Japan. The company expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia.
The company noted that the commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration recently approved a further increase in manufacturing capacity.
Kymriah is the FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients' immune systems to fight their cancer.
Kymriah is currently approved for the treatment of r/r pediatric and young adult acute lymphoblastic leukemia, and r/r adult diffuse large B-cell lymphoma. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia.
Copyright RTT News/dpa-AFX
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