Novartis’ Kymriah has been given accelerated approval by the US Food and Drug Administration (FDA) for adult patients diagnosed with relapsed or refractory (r/r) follicular lymphoma (FL) who have had two or more previous therapies.
Although follicular lymphoma is commonly an indolent type of cancer – a form that is slow to progress and does not pose an immediate threat – there are a number of treatments available and patients with FL may be given as many as 13 treatments, with diminishing effectiveness.
Kymriah (tisagenlecleucel) has now been approved by the FDA for three indications and it remains the only current CAR-T cell treatment approved for both adult and paediatric patients. It can be given to patients in an outpatient setting, which will potentially reduce the burden of treatment on both patients and their respective care teams.
The FDA based its decision for approval on data from the ELARA phase 2 trial, which assessed 90 patients for efficacy with a median follow-up of around 17 months. The single-arm, open-label trial showed that 86% of patients administered Kymriah achieved a response, which included 68% who experienced a complete response.
“[With] today’s FDA approval of a third indication for Kymriah, we hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, president, Novartis Innovative Medicines US.
Meghan Gutierrez, CEO at the Lymphoma Research Foundation, said: “The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes.
“Having this single infusion treatment option helps to transform the way healthcare providers approach this type of blood cancer and we commend those who have contributed to the acceleration of scientific research for the benefit of patients.”
As part of the Accelerated Approval Programme, the clinical benefit of this treatment will need to be verified in further confirmatory trials to receive continued approval.
The European Commission approved Kymriah in the EU in early May 2022 to treat adult patients with r/r FL who have had two or more previous therapies.