Novartis has secured priority review from the US Food and Drug Administration (FDA) for the supplemental biologics licence application (sBLA) of its Kymriah (tisagenlecleucel) to treat relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

The approval covers patients who are not eligible for or failed autologous stem cell transplant (ASCT).

Additionally, the European Medicines Agency (EMA) permitted accelerated assessment to the drug’s marketing authorisation application (MAA) for paediatric and young adults with r/r B-cell acute lymphoblastic leukaemia (ALL), as well as adults suffering from r/r DLBCL and ineligible for ASCT.

Kymriah is a chimeric antigen receptor T-cell (CAR-T) therapy that was initially approved by the FDA in August 2017 to treat refractory B-cell precursor ALL patients aged up to 25 years.

“We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

Novartis Oncology Global Drug Development head Samit Hirawat said: “The priority review designation and accelerated assessment signal that the FDA and EMA have recognised the potential of Kymriah to provide a much-needed therapeutic option for these patients with r/r B-cell ALL and DLBCL.

“We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients.”

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Both the US and European regulatory applications included findings from the firm’s global clinical trial programme conducted in r/r B-cell ALL and DLBCL patients to assess the safety and efficacy of Kymriah.

Over the coming months, the firm intends to submit additional regulatory applications for Kymriah in markets outside the US and European Union (EU).