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The FDA (cilta-cel; Carvykti), the second chimeric antigen receptor (CAR) T-cell therapy for adults with relapsed or refractory multiple myeloma, Janssen Pharmaceuticals announced.

Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed CAR T-cell immunotherapy, is indicated for patients who have received four or more lines of therapy, based on the results of the . In the phase Ib/II study, one-time treatment resulted in an overall response rate of 98%, with 78% of patients achieving a stringent complete response. Median duration of response was 21.8 months.

"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 principal investigator Sundar Jagannath, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in a press release. "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."

CARTITUDE-1 included 97 patients who had received a median of six prior therapies (range 3-18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Prescribing information for ciltacabtagene autoleucel includes a boxed warning for cytokine release syndrome (CRS), which occurred in 95% of patients, as well as for immune effector cell-associated neurotoxicity syndrome, parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

Aside from CRS, other common adverse events (>20%) included pyrexia, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections of unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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