Novartis wins EU approval for CAR-T therapy

Aug 27, 2018

Novartis announced that the European Commission has approved Kymriah for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia.

Kymriah, the first CAR-T cell therapy ever approved by the U.S. FDA, is a ground-breaking one-time treatment that uses a patient's own T cells to fight cancer, and the only chimeric antigen receptor T cell  therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies.

Novartis expects to launch initially for pediatric indications, as the drugmaker continues to ramp up capacity. Novartis has been actively pursuing options to expand manufacturing capabilities beyond its facility in Morris Plains, New Jersey. This includes our agreement with France-based CDMO, CELLforCURE.

Read the press release

Want to get news like this in your inbox?  Subscribe to our eNewsletter here!

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments