FDA and EMA approve Novartis’ treatment for follicular lymphoma patients

pharmafile | October 27, 2021 | News story | Research and Development  

The FDA and EMA have accepted Novartis’ Supplemental Biologics License Application (sBLA) and Type II Variation for KymriahⓇ in patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment. 

Kymriah also received orphan drug designation from the European Commission (EC) for patients with FL earlier this year. It is the first-ever-FDA-approved CAR-T cell therapy and is currently available in 30 countries in one or more indications, with more than 345 certified treatment centers worldwide.

If Kymriah is approved in this potential third indication, Kymriah would have the opportunity to present an important treatment option for those patients with r/r FL in need of potentially definitive outcomes.

The regulatory submissions are based on positive data from the pivotal Phase II ELARA trial, which investigated the efficacy and safety of Kymriah in adult patients with r/r FL. The trial met its primary endpoint, and the safety profile was exceptional, as no patients experienced grade 3 or higher cytokine release syndrome (CRS) related to Kymriah within the first 8 weeks following infusion. 

Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis, said: “This is an important milestone in our mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma. Receiving orphan drug designation from the EC as well as priority review from the FDA underscores the unmet need and urgency for these patients. With Kymriah demonstrating impressive results in the ELARA trial, we are hopeful that we can offer a unique and potentially definitive treatment that minimizes the burden.”

Kymriah is currently approved by the FDA, EMA, and other regulatory authorities for the treatment of r/r pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL). 

Lina Adams


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