On May 27, 2022, Kymriah FDA Approved it For the Treatment of Relapsed or Refractory Follicular Lymphoma (FL)
On May 27, 2022, Kymriah FDA Approved it For the Treatment of Relapsed or Refractory Follicular Lymphoma (FL)
Follicular lymphoma (FL) is the most common indolent lymphoma and the second most common type of lymphoma globally, accounting for approximately 22% of newly diagnosed lymphomas worldwide. Currently, there is no standard treatment for relapsed/refractory FL. Patients with follicular lymphoma that relapses after two lines of treatment have a five-year survival rate of only 20%.
On May 27, 2022, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Kymriah (Tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
Notably, this approval marks the third indication for Kymriah (tisagenlecleucel) and makes it the only CAR-T cell therapy approved in both the adult and pediatric settings.
Under the accelerated approval program, continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This approval is based on positive data from the Phase II ELARA trial, a single-arm, open-label study that evaluated the efficacy in 90 patients, with a median follow-up of approximately 17 months. Among patients treated with Kymriah, 86% achieved a response, with 68% achieving a complete response.
It is estimated that 85% of patients maintained complete response at 12 months after the initial response, demonstrating a durable long-term response to the treatment. Kymriah was shown to be effective in high-risk patients, including those who had received extensive pretreatment or had refractory disease, POD24, bulky disease, or a high Follicular Lymphoma International Prognostic Index (FLIPI) score.
In terms of safety, 53% of patients experienced cytokine release syndrome (CRS), with no Grade 3 or higher CRS. Neurological events occurred in 43% of patients, with 6% experiencing Grade 3 or higher neurological events.
The primary analysis data presented at the 2021 American Society of Clinical Oncology (ASCO 2021) meeting showed that patients treated with Kymriah achieved a complete response rate of 66% and an overall response rate of 86%, meeting the primary endpoint.
The approval of the third indication for Kymriah will provide a potential new treatment option for patients with relapsed or refractory follicular lymphoma.
Content Source:香港济民药业Drugs