The shortage of manufacturing slots for CAR-T cells, which has left myeloma patients dying on a waitlist, came as a surprise to drugmakers and clinicians alike.
When the Food and Drug Administration approved the first myeloma CAR-T product from Bristol Myers Squibb in spring of 2021, there were already four other lymphoma and leukemia CAR-T therapies on the market. Those weren’t facing severe supply constraints so people hadn’t expected there to be issues supplying ide-cel, Bristol’s myeloma CAR-T, said Yi Lin, the director of the cell therapy program at the Mayo Clinic. But after the approval, the demand quickly overwhelmed Bristol’s ability to create CAR-T for myeloma — and supply chain issues during the pandemic made it more difficult to ramp up production.
STAT talked about such challenges with some of the established pharmaceutical companies that have been entering the cell therapy market, like Bristol, Novartis, and Janssen, along with newer biotech companies in the space like Ori Biotech and Orgenesis. They were split on whether the supply problem was getting better or at risk of getting worse.