Novartis Receives CHMP Support for Kymriah with 69% Complete Response Rate in Relapsed/Refractory Follicular Lymphoma
Novartis
Drug Development and Manufacturing
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
On March 26, Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) supported the approval of expanding the indication for the CAR-T therapy Kymriah (tisagenlecleucel) to treat patients with relapsed/refractory follicular lymphoma who have received two or more systemic therapies. If approved, this would be the third indication for Kymriah in the EU. The regulatory application for this indication in the United States has also received priority review status.
Follicular lymphoma is the second most common non-Hodgkin lymphoma (NHL), and as an indolent lymphoma, it accounts for approximately 22% of NHL cases. About 20% of patients will experience disease progression within 2 years after receiving first-line treatment. Although patients receiving third-line or beyond treatments have multiple systemic treatment options, the efficacy of these regimens diminishes rapidly in later stages of treatment. Therefore, there is an urgent need for new, durable treatment options for refractory patients or those who relapse after two prior treatments.
Kymriah is the first CAR-T therapy to receive FDA approval, targeting the CD19 antigen. It has been approved by the FDA and the EU for the treatment of relapsed/refractory acute lymphoblastic leukemia and diffuse large B-cell lymphoma.
The positive opinion of the CHMP is based on the positive results of a global Phase 2 clinical trial. Among 94 evaluable patients, with a median follow-up time of approximately 17 months, Kymriah achieved an overall response rate of 86% and a complete response rate of 69%. Eighty-seven percent of patients who achieved complete response remained in remission nine months after their initial response.
In terms of safety, among 97 patients evaluable for safety, 49% experienced cytokine release syndrome (CRS), with no grade 3 or higher CRS. The incidence of grade 3 or 4 neurological events within 8 weeks of infusion was 3%.
Note: The original text has been abridged.
References:
[1] Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe. Retrieved March 25, 2022, from https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-kymriah-car-t-cell-therapy-adult-patients-relapsed-or-refractory-follicular-lymphoma-europe
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