The Food and Drug Administration will require companies that make CAR-T cell immunotherapies, a specialized treatment for certain blood cancers, to include a black box warning that states the treatment itself may also cause cancer.
A black box warning is the most serious safety alert the FDA will assign to a medication. This new requirement comes months after the agency investigated reports that users of the specialized therapies were getting T-cell malignancies, a type of cancer that originates in the white blood cells that are involved in a person's immune system.
“We have become aware of the risk of T cell malignancies, with serious outcomes, including hospitalization and death, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies,” the FDA said last week in individual letters addressed to the six pharmaceutical companies that manufacturer the CAR-T treatments.
Those companies and corresponding medications are Bristol-Myers Squibb, maker of Abecma; Juno Therapeutics, maker of Breyanzi; Janssen Biotech of Johnson & Johnson, maker of Carvykti; Novartis, maker of Kymriah; and Kite Pharma, maker of Tecartus and Yescarta.
A few days later, the FDA revised its original letter in regard to Tecartus, no longer stating that patients have experienced T-cell malignancies from using that specific therapy brand but still requiring the company to include the warning.
The black box warning that the agency has asked the companies to include states, “T-cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including,” followed by the product’s name. The same language is also required as part of the “secondary malignancies” item in the less prominent “Warnings and Precautions” section of a drug’s label.
While the FDA said the overall benefits of these products continue to outweigh their potential risks for their approved uses, it still wants patients to be aware of all the risks after reviewing the claims.
The FDA has not said how many cases it reviewed before issuing this label requirement.
The companies notified now have 30 days to either meet the FDA’s demand and submit a supplement with the proposed label changes or they can submit a rebuttal statement detailing why they believe the warning label is not necessary. If they choose none of the above, the companies could face potential enforcement action, including monetary penalties, the FDA said in the letters.
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