Kymriah receives approval for commercial manufacturing in Japan

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Japan’s Ministry of Health, Labor and Welfare has issued marketing authorization for Foundation for Biomedical Research and Innovation at Kobe to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan.

Kymriah is sponsored by Novartis.

Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where FDA approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR T-cell therapy, and the first-ever CAR-T to be approved in two distinct indications. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia, and r/r adult diffuse large B-cell lymphoma (DLBCL).

Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR T-cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania.

Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers.


The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).

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