![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » European Commission Gives Okay to Novartis’ Kymriah for Follicular Lymphoma
European Commission Gives Okay to Novartis’ Kymriah for Follicular Lymphoma
May 5, 2022
The European Commission has approved Novartis’ chimeric antigen receptor (CAR)-T drug Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed/refractory follicular lymphoma after two or more lines of systemic therapy.
The approval marks the EU’s third indication for the intravenous infusion drug. Other approved indications are for diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia (ALL).
The new approval was supported by results from a late-stage study in which 86 percent of participants taking Kymriah had a positive response, including 69 percent who had a complete response. The complete response was sustained at nine months or longer in a large percentage of patients.
The FDA approved Kymriah in August 2017 for treatment of patients up to age 25 years with B-cell precursor ALL that is refractory or in second or later relapse, making it the first gene therapy to be approved in the U.S.
The cancer therapy costs $475,000 for one course of treatment.
Upcoming Events
-
21Oct