FDA approves earlier use of Carvykti CAR-T for multiple myeloma
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The FDA approved ciltacabtagene autoleucel for earlier use in certain adults with relapsed or refractory multiple myeloma.
The expanded indication permits treatment with the chimeric antigen receptor T cells after first relapse and applies to adults who are refractory to lenalidomide and have received at least one previous line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Ciltacabtagene autoleucel (Carvykti; Janssen, Legend Biotech), also referred to as cilta-cel, is a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy previously approved for use in adults with relapsed or refractory multiple myeloma after four lines of treatment.
“Carvykti demonstrated remarkable efficacy as a personalized, one-time infusion in the earlier treatment of relapsed [or] refractory multiple myeloma as shown through the CARTITUDE-4 study results,” Binod Dhakal, MD, associate professor of medicine at the Medical College of Wisconsin, said in a press release. “With this approval, I’m excited for patients who may have the opportunity for a treatment-free period for their multiple myeloma as early as first relapse, with the hope of eliminating the burden of having to be on continuous treatment while living with this challenging disease.”
Cilta-cel reduced disease progression or death by 59% when used as an earlier line of treatment compared with standard therapy in the phase 3 CARTITUDE-4 trial, according to the release.
Healio previously reported an FDA advisory committee unanimously recommended earlier use of cilta-cel despite concerns of early death rates.
In the CARTITUDE-4 trial, patients in the cilta-cel arm had a higher total mortality rate compared with standard therapy — including mortality within the first 10 months following treatment randomization — but still had a positive risk-benefit analysis in the eyes of the committee.
“Improving access to this treatment will improve overall outcomes for all individuals,” Susan Lattimore, RN, GCPH, associate director of the hemostasis and thrombosis center at Oregon Health and Science University, said during that meeting.
Common adverse events associated with cilta-cel include pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation and vomiting.
Common grade 3 and grade 4 adverse events associated with cilta-cel include lymphopenia, neutropenia, decreased white blood cell count, thrombocytopenia and anemia.
Cilta-cel has boxed warnings for CRS, immune effector cell-associated neurotoxicity syndrome, Parkinsonism and Guillain-Barre syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged and recurrent cytopenias and secondary malignancies.
“This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with Carvykti,” Jordan Schecter, MD, vice president and disease area leader of multiple myeloma for Johnson & Johnson Innovative Medicine, said in the release. “We are proud to bring an important, highly effective immunotherapy that has demonstrated a favorable benefit/risk profile to physicians and patients for the earlier treatment of relapsed [or]refractory multiple myeloma, and we look forward to building on this latest milestone as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma.”
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