FDA’s CAR T Probe ‘Not a Big Deal’ for Oncology-Focused Biotechs: Triumvira President

January 10, 2024

The CAR T sector has been under the regulatory microscope since the FDA announced in late November 2023 that it was investigating 20 reports of T cell lymphoma in patients who had previously received CAR-T therapies. However, at least one cell therapy oncology company is not concerned.

At the 42nd J.P. Morgan Healthcare Conference, Triumvira Immunologics President and Chief Operating Officer Rob Williamson told BioSpace that internal discussions and those with other analysts and oncology-based cell therapy companies indicate the investigation is not a “big deal.” He was also adamant that it would not affect Triumvira and its business.

“(For) these patients, the risk-benefit is significantly in favor of the therapy,” Williamson said.

That is not to say that the CAR T industry has not had some rough times recently or that everything is sailing along smoothly.

“I think cell therapy within biotech is still in the penalty box,” Williamson said. He said cell therapy companies may continue to be seen less favorably than other biotechs during the next year, except for those who can differentiate themselves in showing value, good efficacy data or by targeting unmet needs. He said he is hopeful that cell therapy can get out of this penalty box, “but it’s a very crowded space.”