Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021.
Novartis today announced that the US FDA granted regenerative medicine advanced therapy designation to Kymriah (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).
The potential approval in r/r FL will be the third indication for Kymriah, which also has indications in r/r paediatric and young adult acute lymphoblastic leukaemia, and r/r adult diffuse large B-cell lymphoma.
