Posted by Michael Wonder on 05 Sep 2020
Kite submits supplemental biologics license application to U.S. FDA for Yescarta in relapsed or refractory indolent non-Hodgkin's lymphomas
4 September 2020 - If approved, Yescarta would be the first CAR T therapy for patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma.
Kite today announced that it has submitted a supplemental biologics license application to the U.S. FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy.
Yescarta was previously granted breakthrough therapy designation by the FDA for these indications.
