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The agency needs more time to review new information on the analytical method used.
The FDA has extended the review of Janssen’s biologics license application for ciltacabtagene autoleucel (cilta-cel) to Feb. 28, 2022. The extension was implemented to give the agency time to review information provided by the company on the analytical method. This information was requested by the FDA. No additional clinical data have been requested.
Cilta-cel is a B-cell maturation antigen (BCMA) chimeric antigen receptor T cell (CAR-T) therapy, is being investigated for the treatment of adults with multiple myeloma. Janssen had initiated its rolling submission in December 2020.
In June 2021, Janssen released updated data from the CARTITUDE-1 phase 1b/2 study, which found that cilta-cel demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma. Results with 97 patients with a longer-term follow-up at a median of 18 months showed an overall response rate ORR of 98%, with 80% of patients achieving a stringent complete response.
Additionally, 66% of patients were progression free and alive at 18 months. The study included patients who had received a median of six prior treatment regimens. Data presented at the American Society of Clinical Oncology Annual Meeting in June 2021 showed an overall survival of 81%.
Both CARTITUDE-1 and the phase 2 CARTITUDE-2 are ongoing.
Cilta-cel was developed by Legend Biotech, and in December 2017, Janssen Biotech entered into a collaboration agreement with Legend Biotech to develop and commercialize cilta-cel.
Multiple myeloma is a cancer that develops in white blood cells. In patients with multiple myeloma, cancer cells accumulate in the bone marrow, crowding out healthy cells. Most patients are diagnosed because of symptoms such as bone fracture or pain, low red blood cell counts, high calcium levels, kidney problems or infections. The American Cancer Society predicts almost 35,00 new cases of multiple myeloma will be diagnosed in 2021 and there will be more than 12,000 deaths this year.