Hematological Neoplasms

On February 23, 2024, Legend Biotech announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of expanding the indication for CARVYKTI® (cilta-cel, Ciltacabtagene Autoleucel) to include adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy (including an immunomodulatory agent and a proteasome inhibitor), and have progressed on the last line of therapy and are refractory to lenalidomide.

Johnson & Johnson and Legend Biotech’s jointly developed chimeric antigen receptor (CAR) T-cell therapy Carvykti (ciltacabtagene autoleucel, cilta-cel) has been approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

On April 5, 2024, local time, Legend Biotech (NASDAQ: LEGN) announced in Somerset, New Jersey, USA, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide1.

On February 23, 2024, Legend Biotech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of an expanded indication for Carvykti (cilta-cel, Ciltacabtagene Autoleucel) to include adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy (including an immunomodulatory agent and a proteasome inhibitor) and have progressed on their last line of therapy and are refractory to lenalidomide.

CARVYKTI® (Cilta-cel, Ciltacabtagene Autoleucel) is the first product of Legend Biotech to be approved by the European Commission (EC).

Carvykti (Ciltacabtagene Autoleucel, cilta-cel) is a chimeric antigen receptor T-cell (CAR-T) immunotherapy targeting the B-cell maturation antigen (BCMA).

Chimeric antigen receptor T-cell (CAR-T) immunotherapy is a novel therapeutic approach that utilizes the patient’s own immune system to combat cancer cells.

BCMA-targeted CAR-T cells have shown excellent effects for relapsed or refractory multiple myeloma, with complete and very good partial remission rates of 50%-90%.

At the Bone Marrow Transplantation Center of the First Affiliated Hospital of Zhejiang University School of Medicine in China, there is a “Pharmacy God” team that wrestles with the Grim Reaper every day. They use the latest cell therapy technique – Chimeric Antigen Receptor T-cell (CAR-T) therapy to treat malignant hematological diseases, with a success rate of over 90%. Currently in the clinical trial stage, the cost of CAR-T cell preparation is free.

Based on the excellent clinical data, in December 2019, the FDA granted Ciltacabtagene Autoleucel “Breakthrough Therapy Designation”; in February 2020, the European Commission granted it “Orphan Drug Designation”; on June 5, 2020, Legend Biotech officially went public on NASDAQ. In August 2020, Ciltacabtagene Autoleucel also received the first “Breakthrough Therapy” certification from the China National Medical Products Administration (NMPA) Center for Drug Evaluation.

On March 1, 2022, Genscript Biotech officially announced that its subsidiary Legend Biotech’s CAR-T product Carvykti (Ciltacabtagene autoleucel) received FDA approval.

From the current medical perspective, it is still uncertain whether CAR-T can cure multiple myeloma.