Novartis' revolutionary CAR-T cell therapy Kymriah, used to treat patients with leukemia and lymphoma, has been used in about 1,800 patients, but the company is still struggling to meet FDA standards for the treatment, according to BioPharma Dive.
CAR-T cell drugs are made by extracting a patient's T cells and then freezing and shipping them to a manufacturing facility, where the cells are genetically engineered to target cancers expressing certain proteins. It takes Novartis an average of 21 days to make a dose of Kymriah.
However, about 10 percent of the time, Novartis hasn't been able to ship a dose of Kymriah, either because of manufacturing failures or out-of-specification issues, according to BioPharma Dive.
Out-of-specification issues happen when a drug doesn't meet the standards the FDA set for it when it was approved.
When the FDA approved Kymriah, it was required to contain at least 80 percent viable T cells, meaning the cells are alive and active. But 29 lymphoma patients treated with Kymriah received a dose with less than 80 percent, as did 14 leukemia patients, according to BioPharma Dive.
While data has shown that patients who receive doses with less than 80 percent viable cells have no greater safety risks, Novartis isn't allowed to make money off these out-of-specification doses. It isn't clear how much this has affected Kymriah sales.
Novartis said it is making progress in addressing manufacturing issues related to Kymriah, but also said the same thing last year and continues to have the same manufacturing issues, according to BioPharma Dive.
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