Kymriah receives approval for commercial manufacturing in Japan

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.

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Kymriah receives approval for commercial manufacturing in Japan

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Kymriah receives approval for commercial manufacturing in Japan

YOU MAY BE INTERESTED IN

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patientsCaveat: The guidance is optional. Will states opt in?

Scientific progress can’t help people if they can’t access careThis is a policy problem. And it is one we can change.

The end of “more money, more people, more trials”Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words“When you fight poverty, you‘re fighting a humanitarian battle for all people.”

Never miss an issue!

Login

Letai takes a swipe at “ill-informed commentators,” as he lays out his scientific vision for NCI
“To my knowledge, 100% of grants that clear my desk get funded”

As Medicaid work requirements loom, CMS guidance offers automatic exemptions for some cancer patients
Caveat: The guidance is optional. Will states opt in?

Scientific progress can’t help people if they can’t access care
This is a policy problem. And it is one we can change.

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Harold Freeman, a surgeon who championed health equity, dies at 93
Freeman, the father of patient navigation, served as president of ACS and chair of the President’s Cancer Panel

Harold Freeman in his own words
“When you fight poverty, you‘re fighting a humanitarian battle for all people.”