FDA Clears New CAR-T Therapy for Multiple Myeloma

FDA approved Legend Biotech’s chimeric antigen receptor T-cell (CAR-T) treatment, Carvykti (ciltacabtagene autoleucel; cilta- cel), to treat relapsed or refractory multiple myeloma (RRMM) who have received four or more prior lines of therapy.

Legend Biotech, which has an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta- cel, said in a news release the therapy will be available by mid-March.

Through a phased approach, Legend and Janssen will activate a limited network of certified treatment centers as they work to scale production capacity and increase the availability of Carvykti throughout the US in 2022 and beyond, “ensuring that the Carvykti treatment can be provided to oncologists and their patients in a reliable and timely manner,” Legend said.

“Multiple myeloma remains an incurable disease with heavily pretreated patients facing poor prognoses with limited treatment options,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. The drug has the potential to become an impactful therapy option for patients in need of long, treatment-free intervals, Huang added.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse with fewer patients achieving a deep response as they progress through later lines of therapy,” said Dr. Sundar Jagannath, professor of medicine, hematology and medical oncology at Mount Sinai and principal study investigator.

The CARTITUDE-1 study, which the approval is based on, demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, “even in this heavily pretreated multiple myeloma patient population,” Jagannath added.

Carvykti is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) program. The Safety Information for the drug includes a Boxed Warning regarding Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), and prolonged and/or recurrent cytopenia.

Warnings and Precautions include prolonged and recurrent cytopenias, infections, hypogammaglobulinemia, hypersensitivity reactions, secondary malignancies and effects on ability to drive and use machines.