A multiple myeloma diagnosis can be devastating. Encouragingly, though, the market is getting increasingly crowded with powerful new therapies that can extend patients’ lives. Cell therapy is one particular area of great hope, with clinical data from Johnson & Johnson’s Carvykti driving excitement in the medical field and on Wall Street.
A late-stage study released earlier this year showed the treatment cut the risk of relapse by 74% compared with the standard of care—a level of efficacy seen as game-changing by experts, though with potentially serious side effects. There is a major hitch, though: J&J and its partner, Legend Biotech, can’t keep up with demand, which means some patients die on wait lists. The companies have vowed to scale up manufacturing as quickly as possible, but it won’t be easy.
The issue isn’t limited to J&J: A similar therapy from competitor Bristol-Myers Squibb, Abecma, also faces manufacturing hurdles. Making these engineered human cell products known as CAR-Ts is a complex and individualized process. The treatment involves removing T cells from a patient’s blood, modifying them in a lab to fight cancer and then infusing them back into the patient.
It takes several weeks for the cells to be shipped back and forth between the medical centers and the labs—an agonizing process for very sick patients. While J&J and Legend say they are doing everything they can to increase manufacturing, the process is basically bespoke, which means economies of scale don’t apply. “Intrinsically, it’s very, very different from the typical manufacturing methodology for pharmaceuticals," explains Legend Chief Executive Officer Ying Huang.
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