The FDA has delayed the approval of a new BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy called ciltacabtagene autoleucel (cilta-cel). The drug, co-developed by Legend Biotech and Johnson & Johnson (both NJ, USA), is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma.
“We remain confident that cilta-cel has shown great promise in patients with relapsed and refractory multiple myeloma, and we are focused on making this therapy available to them in the US as soon as possible,” commented Ying Huang, Chief Executive Officer and Chief Financial Officer at Legend Biotech.
The three-month delay has come after the FDA requested more time to review information regarding an updated analytical method to measure the therapy’s potency. However, no additional clinical data has been requested.
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Current therapeutic options for multiple myeloma, a type of blood cancer, include Abecma — a recently approved BCMA targeting cell-therapy developed by Bristol Myers Squibb (NY, USA) and Bluebird bio (MA, USA). Both cilta-cel and Abecma have produced promising trial outcomes – with Abecma eliminating or reducing signs of disease in 72% of patients in the main study, compared to 97% in cilta-cel’s chief trial.
These are welcome results, considering that the first approved BCMA-targeting drug on the market, Blenrep, can cause side effects including vision loss.
The delay in the approval of cilta-cel could boost Abecma sales – which have already surpassed Blenrep by US$4 million despite being on the market for less time.
The FDA are expected to reach their decision on cilta-cel by February 28, 2022.