FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98% response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
The U.S. Food and Drug Administration (FDA) has approved Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulator and an anti-CD38 monoclonal antibody.
The approval is based on data from the pivotal Cartitude-1 study, which included patients who had received a median of six prior treatment regimens (range, three to 18) and had previously received a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Carvykti is a CAR-T (Chimeric Antigen Receptor T-cell) therapy comprising two single-domain antibodies targeting B-cell maturation antigen (BCMA). In the pivotal Cartitude-1 study, single treatment with ciltacabtagen autoleucel resulted in profound and durable responses, with 98% of patients with MMRR responding to treatment (98% overall response rate [ORR] (n=97). Notably, 78% of patients achieving this level of response (n=76) experienced strict complete response (sCR), an extent to which a physician is unable to observe signs or symptoms of disease via imaging or further tests after treatment. After a median follow-up of 18 months, the median duration of response (DOR) was 21.8 months.
Carvykti is only available under a restricted program under a Risk Assessment and Mitigation Strategy (REMS) called the Carvykti REMS program.
“We are committed to harnessing our science, deep disease understanding and capabilities to advance cell therapies like Carvykti as we continue to focus on our ultimate goal of providing a cure for multiple myeloma,” commented Dr. Peter Lebowitz, Global Therapeutic Area Leader, Oncology, Janssen Research and Development, LLC.
Multiple myeloma is an incurable blood cancer that affects plasma cells found in the bone marrow. Despite the development of additional treatment options in recent years, most people living with multiple myeloma face poor prognoses after experiencing disease progression after treatment with three major therapeutic classes, which include an immunomodulatory agent , a proteasome inhibitor and an anti-CD38 monoclonal antibody.
“The responses from the Cartitude-1 study showed durability over time and enabled the majority of heavily pretreated patients to achieve profound responses after an 18-month follow-up,” said Dr. Sundar Jagannath, director of the Center of Excellence for Multiple Myeloma. and professor of medicine, hematology and medical oncology at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and principal investigator of the study. “Cilta-cel’s approval provides physicians with an immunotherapy treatment option that offers patients the ability to be free of anti-myeloma therapies for a period of time.”
As personalized medicine, Carvykti treatment requires extensive training, preparation and certification to ensure a positive patient experience. Through a phased approach, Janssen and Legend Biotech will activate a limited network of certified processing centers as the company strives to scale production capacity and increase availability of Carvykti in the U.S. in 2022 and beyond. -of the.