Subscribe

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive:

Carvykti Second BCMA-Directed CAR T-Cell Therapy FDA Approved for Multiple Myeloma

JHOP - April 2022 Vol 12, No 2 - FDA Oncology Update, CAR T-Cell Therapy, Multiple Myeloma
NEW DRUGS
Download PDF

On February 28, 2022, the FDA approved ciltacabtagene autoleucel (Carvykti; Janssen Biotech) for the treatment of adults with relapsed or refractory multiple myeloma after ≥4 lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. It is the second BCMA-directed CAR T-cell therapy approved by the FDA for this patient population. The FDA granted this application a priority review, a breakthrough therapy designation, and an orphan drug designation.

The FDA approval of this new CAR T-cell therapy was based on results of the CARTITUDE-1 clinical trial, an open-label, phase 1/2 multicenter study of 97 patients with relapsed or refractory multiple myeloma who received ≥3 previous lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, whose disease progressed during or after the last chemotherapy regimen; 82% of the patients had received ≥4 lines of antimyeloma therapy.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” said Sundar Jagannath, MD, Director, Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, The Tisch Cancer Institute, Icahn School of Medicine, Mount Sinai, and principal study investigator. “The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time.”

The overall response rate (ORR) and the duration of response (DOR) with ciltacabtagene autoleucel were evaluated using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. The ORR was 97.9% (95% confidence interval [CI], 92.7-99.7). Among the 95 patients who had a response to the CAR T-cell therapy, the median DOR was 21.8 months (95% CI, 21.8-not evaluable), with a median duration of follow-up of 18 months.

The drug’s prescribing information includes a boxed warning for cytokine-release syndrome (CRS), hemophagocytic lymphohistiocytosis or macrophage activation syndrome, immune effector cell–associated neurotoxicity syndrome, Parkinson disease, Guillain-Barré syndrome, and prolonged and/or recurrent cytopenia, all of which are life-threatening.

The most common adverse reactions with ciltacabtagene autoleucel were pyrexia, CRS, hypogammaglobulinemia, musculoskeletal pain, fatigue, infections, diarrhea, nausea, encephalopathy, headache, coagulopathy, constipation, and vomiting.

Ciltacabtagene autoleucel is approved with a Risk Evaluation and Mitigation Strategy program requiring that providers who administer this medication must be certified to recognize and manage CRS and neurologic adverse events. The FDA is requiring the manufacturer to conduct a postmarketing study to verify the safety of the drug in patients who received ciltacabtagene autoleucel.

Related Items
Gavreto Received Regular FDA Approval for Patients With Non–Small Cell Lung Cancer and RET Gene Fusion
Online First published on September 8, 2023 in FDA Oncology Update
FDA Accelerated the Approval of Akeega, First and Only Dual-Action Tablet for Metastatic Prostate Cancer With BRCA Mutation
Online First published on September 8, 2023 in FDA Oncology Update
FDA Granted Accelerated Approval to Elrexfio, a Bispecific BCMA-Directed CD3 T-Cell Engager, for Relapsed or Refractory MM
Online First published on September 8, 2023 in FDA Oncology Update
Hepzato Kit FDA Approved as a Liver-Directed Treatment for Uveal Melanoma With Hepatic Metastases
Online First published on September 8, 2023 in FDA Oncology Update
FDA Accelerated the Approval of Talvey, First Bispecific GPRC5D-Directed CD3 T-Cell Engager, for Relapsed or Refractory MM
Online First published on September 8, 2023 in FDA Oncology Update
FDA Accelerated the Approval of Columvi for Selected Relapsed or Refractory Large B-Cell Lymphomas
JHOP - August 2023 Vol 13, No 4 published on August 17, 2023 in FDA Oncology Update
Lonsurf Received a New Indication, in Combination With Bevacizumab, for Previously Treated Metastatic Colorectal Cancer
JHOP - August 2023 Vol 13, No 4 published on August 7, 2023 in FDA Oncology Update
Jemperli Plus Chemotherapy Now FDA Approved for Front-Line Treatment of dMMR or MSI-H Endometrial Cancer
JHOP - August 2023 Vol 13, No 4 published on August 4, 2023 in FDA Oncology Update
Vanflyta Now Approved for Newly Diagnosed FLT3-ITD–Positive AML
JHOP - August 2023 Vol 13, No 4 published on July 28, 2023 in FDA Oncology Update
Talzenna Received a New Indication, With Enzalutamide, for Metastatic Castration-Resistant Prostate Cancer With HRR Gene Mutation
JHOP - August 2023 Vol 13, No 4 published on June 30, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.