Will Black Box Warning Affect Development of CAR-T Therapy

Abstract

Cell therapy has emerged as an approved treatment and has saved many patients. As a living therapy, it serves as a role model for advancements in biology, especially in combating cancer to some extent. Despite the progress in cell therapy, one of the biggest issues on the regulatory side is that the FDA now requires a black box warning for the six cell therapies currently on the market. This announcement was made on January 22nd 2024, mandating producers to remind users about the risk of developing lymphoma. To date, all companies have put the black box warning in their product sheet.
After the announcement, there was a rapid change in the stock market for related companies. However, based on our analysis, there is no need to overreact to such regulatory changes.