In the CARTITUDE-1 study, 98% of patients with RRMM responded to a one-time treatment with Carvykti, while 78% achieved a stringent complete response
Janssen partnered with Legend Biotech for Carvykti. (Credit: Vysotsky/Wikipedia)
Janssen, together with its partner Legend Biotech, has received the US Food and Drug Administration (FDA) approval for their Carvykti to treat a type of multiple myeloma.
The drug was indicated for relapsed or refractory multiple myeloma (RRMM) in adults, after prior treatment using proteasome inhibitor (PI), immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
Carvykti (ciltacabtagene autoleucel; cilta-cel) is a CAR-T immunotherapy designed to identify and destroy the cells that express B-cell maturation antigen (BCMA).
BCMA is predominantly expressed on the surface of malignant multiple myeloma B-lineage cells, along with late-stage B-cells and plasma cells.
In December 2017, Janssen Biotech and Legend Biotech have initially reached an exclusive worldwide license and collaboration deal to develop and commercialise the drug.
The drug has been granted Breakthrough Therapy Designation in the US and China, and Orphan Drug Designation in the US and the European Commission.
In April last year, Janssen has filed a marketing authorisation application (MAA) with the European Medicines Agency, seeking regulatory approval for Carvykti in multiple myeloma.
Janssen research and development oncology global therapeutic area head Peter Lebowitz said: “We are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like Carvykti as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma.
“We extend our sincere gratitude to the patients, their families and the teams of researchers and study centres who have participated in the clinical study of Carvykti and enabled today’s approval.”
The FDA approval is supported by data from the CARTITUDE-1 study, an ongoing Phase 1b/2, open-label, multi-centre study in 97 patients with RRMM.
In the trial, one-time treatment using Carvykti showed superior and sustained responses, with 98% of RRMM patients responding to the therapy, and 78% of patients achieving stringent complete response (sCR).
The sCR is a measure of treatment response, used when a physician is unable to read any signs or symptoms, obtained using imaging or other tests post-treatment.
Carvykti comes with a Boxed Warning about Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, among others.
Janssen and Legend Biotech will offer the drug as personalised medicine, only through a restricted Risk Evaluation and Mitigation Strategy (REMS) programme.