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FDA Publishes Letter to Novartis Detailing Kymriah Manufacturing Safety Concerns

NEW YORK – The US Food and Drug Administration on Tuesday published a letter that it sent to Novartis on Aug. 8 alerting the drugmaker of concerns about manufacturing safety issues concerning Kymriah (tisagenlecleucel) manufacturing.

In the letter addressed to Novartis Head of Cell & Gene Therapy Robert Zamboldi, the FDA recapped findings from its inspection of Novartis' Morris Plains, New Jersey, manufacturing facility. The inspection took place at the end of 2022.

The FDA notes "significant deviations from current good manufacturing practice" related to Kymriah. For instance, the site investigators noted that Novartis had identified 100 Kymriah batches contaminated with particles of wood, cellulose, brass, and steel — which Novartis attributed to the bags it used at the time to cryopreserve Kymriah — and that the drugmaker had found mold in areas where it manufactured the cell therapy product.

The FDA said in its letter that it had already issued a Form 483 following the inspection, and that Novartis had responded to this form, but that there were still lingering issues with the facility that remained after this response. For instance, Novartis said that it had implemented new processes for better inspecting the bags and identified a new bag supplier, but the FDA asked for studies on the new bags as well as details on how and when Novartis would implement them.

At the end of the August letter, the agency requested Novartis' written response within 30 days to each of the FDA's eight comments. The agency also asked Novartis to meet with the FDA in October to discuss these concerns and its plans for correcting them.

"Patient safety is always our top priority [and] we remain confident in the quality, purity, and potency of every patient lot of Kymriah manufactured and distributed from our Morris Plains site," a Novartis spokesperson wrote via email on Thursday. The spokesperson said that in the wake of the August FDA letter, Novartis has since responded to the agency and has been working to address the findings.

The news of the FDA's August letter to Novartis comes one week after the FDA issued a safety warning about cancer patients developing secondary malignancies following treatment with autologous CAR T-cell therapies. Novartis' Kymriah — the first autologous CAR T-cell therapy ever to be FDA approved back in 2017 — was included on a list of products that had attracted the FDA's concerns.