The Food and Drug Administration (FDA) has given the green light to two competing cell therapies from Bristol Myers Squibb and Johnson & Johnson. The FDA’s decision to expand the approvals of both therapies allows patients to use them as earlier lines of treatment for a type of blood cancer known as multiple myeloma. This is a significant step forward for patients, providing more options in the growing arsenal of treatments for this disease.
Johnson & Johnson’s Drug Gains an Edge
Despite both drugs receiving expanded approvals, Johnson & Johnson’s drug, Carvykti, developed in collaboration with Legend Biotech, has a clear advantage over Bristol Myers’s drug, Abecma. The FDA’s expanded approval allows patients to use Carvykti after just one prior line of therapy for multiple myeloma, given certain conditions. This earlier access to the drug may provide patients with the potential for a treatment-free period earlier in the disease’s progression.
Analysts’ Take on the Market Impact
Analysts believe that the product label difference between the two drugs offers a “significant commercial advantage for Carvykti,” according to Jefferies analyst Kelly Shi. Both Carvykti and Abecma belong to a class of personalized treatments known as chimeric antigen receptor T-cell – or CAR-T – therapies. These work by modifying white blood cells known as T-cells to attack cancer. With the new approval, Shi expects J&J’s drug to win the majority of the market share.
FDA Future Prospects and Challenges
The FDA’s expanded approval of Carvykti could also put it on track to be a blockbuster product for J&J. However, both J&J and Bristol Myers are grappling with the same long-term issue: supply constraints. Both companies have outlined plans to boost production of their respective drugs, and it will be interesting to see how this part of the story plays out later this year.
Mount Sinai’s Approach to AI in Healthcare
Mount Sinai Health System is exploring the use of generative artificial intelligence (AI) in patient care, education, and research. The health system is evaluating use cases across these areas, with a focus on safely helping clinicians and staff speed up decision making. Despite the ongoing hype around generative AI’s potential in healthcare, Mount Sinai is taking a measured approach to its implementation, ensuring that any tool used is safe, feasible, practical, and ethical.
