Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety profile in adult patients with relapsed or refractory follicular lymphoma.
Novartis today announced that the US FDA and the EMA have accepted the company’s supplemental biologics license application and type II variation, respectively, for Kymriah (tisagenlecleucel) in adult patients with relapsed or refractory follicular lymphoma after two prior lines of treatment.
