The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have both respectively accepted Novartis’ Kymriah for review as a treatment for adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two lines of prior treatment.
The FDA also granted the supplemental biologics license application (sBLA) for the CAR-T cell therapy a priority review in this indication.
Previously, Kymriah was granted orphan medicinal product designation by the European Commission for FL.
The regulatory submission for Novartis’ med are based on data from the Phase II ELARA trial, investigating the efficacy and safety of Kymriah in adults patients with r/r FL.
This trial met the primary endpoint with ‘robust responses’ in the heavily pretreated patient population, Novartis said in a statement.
“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,” said Jeff Legos, executive vice president, global head of Oncology & Hematology Development, Novartis.
Currently, Kymriah is approved by the FDA and EMA, as well as additional regulatory authorities, for the treatment of r/r paediatric and young adults with acute lymphoblastic leukaemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL).