Legend Biotech's CAR-T Therapy Carvykti Receives CHMP Positive Opinion for European Marketing Authorization
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
Legend Biotech
Tumor Cell Immunotherapy Developer
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 24, Janssen Pharmaceuticals/Legend Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorization in Europe for Carvykti (ciltacabtagene autoleucel, cilta-cel) to treat adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies, including immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies, and have demonstrated disease progression after their last therapy.
Cilta-cel is an immunotherapy that utilizes chimeric antigen receptor T cells (CAR-T) with two single-domain antibodies targeting B-cell maturation antigen (BCMA). CAR-T therapy is a highly personalized technology that targets and kills cancer cells through a single infusion of genetically engineered autologous T cells from the patient.
Data from the ongoing pivotal CARTITUDE-1 study supported the positive opinion of the CHMP. Two-year follow-up results were presented at the 2021 American Society of Hematology (ASH) Annual Meeting (Abstract #549).
The positive opinion from the CHMP was issued following the approval of cilta-cel for marketing by the U.S. Food and Drug Administration (FDA) on February 28, 2022 (New York time). The favorable CHMP opinion further solidifies cilta-cel's potential for treating patients with multiple myeloma globally.
Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cell found in the bone marrow. Most patients relapse after initial treatment, and the prognosis is poor following treatment with the three main classes of drugs: immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibodies.