By Greis Kapexhiu and Adam J. Fein, Ph.D. In June 2025, the FDA announced that CAR-T therapies would no longer be subject to a REMS program . The FDA’s removal of CAR-T REMS requirements eliminates one obstacle to expanding treatment beyond traditional academic medical centers. That change could disproportionately benefit the Big Three wholesalers, which have spent billions building positions in community oncology while simultaneously investing in cell-and-gene-therapy distribution and support infrastructure. Read on for our review of this dynamic sector and ponder how wholesalers’ community oncology roll-up activities could interact with their cell and gene therapy (CGT) investments. Will…
By
Greis Kapexhiu and
Adam J. Fein, Ph.D.
In June 2025,
the FDA announced that CAR-T therapies would no longer be subject to a REMS program.
The FDA’s removal of CAR-T REMS requirements eliminates one obstacle to expanding treatment beyond traditional academic medical centers. That change could disproportionately benefit the Big Three wholesalers, which have spent billions building positions in community oncology while simultaneously investing in cell-and-gene-therapy distribution and support infrastructure.
Read on for our review of this dynamic sector and ponder how wholesalers’ community oncology roll-up activities could interact with their cell and gene therapy (CGT) investments. Will wholesalers capture a growing share of CAR-T’s economics, or will hospitals continue to hold the upper hand?
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