CAR-T Therapy Drug Cancer Risks Will Be Reviewed at FDA Advisory Committee Meeting Next Month

Observers are waiting to see how the FDA approaches CAR-T therapy safety risks following recently added black box warnings about new cancers.

A panel of scientific advisors will review the safety of CAR-T therapy drugs, focusing on how two of the treatments, Carvykti and Abecma, should be used in light of new warnings about about the potential secondary cancer risks.

Last month, the U.S. Food and Drug Administration (FDA) ordered several manufacturers to add black box warnings to the entire class of medications, indicating that the side effects of CAR-T therapy drugs may increase the risk of T cell malignancies, which can result in hospitalization and death.

The decision came after the agency’s researchers found 22 cases of secondary cancer linked to CAR-T medications, following an investigation that started in November of last year.

According to a Federal Register notice (PDF) issued on February 5, the agency has scheduled a meeting of its Oncologic Drugs Advisory Committee for March 15, at which time the scientific advisors will discuss whether Abecma and Carvykti could be safe and effective for the earlier treatment of multiple myeloma.

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The hearing is highly anticipated by stakeholders because it will give them a glimpse into how the FDA will approach the safety of the drugs after the new cancer warnings. The advisors are expected to focus on the overall survival data from recent clinical trials on the two drugs.

While the FDA often heavily considers the findings of its’ advisory committees when making regulatory decisions, the agency is not obligated to follow their recommendations.

CAR-T Therapy Drug Problems

The CAR-T treatments were approved under a requirement that the FDA conduct a 15-year observational study, to assess the potential for long-term adverse health outcomes and secondary malignancies that could occur after treatment.

The FDA began an investigation into CAR-T cancer risks in November, due to concerns over secondary cancer rates.

By December 31, the agency had found 22 cases of T-cell cancers linked to treatment with CAR-T products, including T-cell lymphoma, T-call large granular lymphocytosis, peripheral T-cell lymphoma and cutaneous T-cell lymphoma. All of the cases examined in detail to date appear to have manifested within two years of treatment.

Some of the cases are still under investigation, but cancer incidents have been reportedly linked to five of the six CAR-T cell drugs on the market, including Abecma, Breyanzi, Carvykti, Kymriah and Yescarta. The sixth drug, Tecarus, had no cases of cancer linked to it, but the FDA required it to also carry a black box warning anyway.

According to the report, in three cases where genetic sequencing was performed, the CAR transgene has been detected in the cancer, indicating that the drugs were probably involved in the development of T-cell cancer incidents.

The agency warns that the cases are still under investigation, and raised concerns that postmarketing reports may underestimate the number of cancer cases caused by the drugs.

As a result of the risks associated with side effects of Carvykti and other CAR-T treatments, the FDA currently recommends that patients or clinical trial participants receiving these treatments be monitored for the rest of their life by a health care professional for new cancers that may develop.

CAR-T Advisory Committee Meeting

The meeting is scheduled for March 15 from 8:30 a.m. to 5:30 P.M. and will be able to be viewed through online teleconferencing and video conferencing. The advisory committee meeting will be open to the public.

The FDA will accept public comment on the meeting until March 14. The docket number is FDA-2024-N-0018. Submissions can be made online through the Regulations.gov electronic filing system.

Comments can also be physically mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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