In a parallel development, J&J and Legend Biotech are gearing up for an FDA meeting in the United States to discuss the expansion of Carvytki into earlier lines of treatment. Legend Biotech CEO, Ying Huang, anticipates that the meeting will predominantly scrutinize overall survival data, despite ongoing concerns about safety associated with CAR-T therapy, particularly the risk of secondary T-cell cancers.
This focus on overall survival underscores the FDA’s recent emphasis on using it as a composite metric for both efficacy and safety evaluation. While Carvytki has demonstrated promising survival benefits, concerns linger regarding potential toxicities, prompting thorough deliberation during regulatory reviews.
Meanwhile, Bristol Myers Squibb (BMS) faces challenges with their CAR-T therapy, Abecma, which failed to exhibit a significant extension in overall survival compared to standard treatments. The FDA remains cautious about negative trends in overall survival, even if attributed to patient crossover in clinical trials.
J&J and Legend remain optimistic about Carvytki’s potential, concurrently addressing manufacturing challenges to ensure product quality and consistency. However, ongoing safety and efficacy concerns underscore the critical need for comprehensive evaluation and discussion in upcoming regulatory proceedings on both sides of the Atlantic.
https://www.fiercepharma.com/pharma/legend-ceo-offers-preview-high-profile-fda-adcomm-jj-partnered-carvykti
https://www.biospace.com/article/eu-regulators-back-j-and-j-legend-s-carvykti-for-second-line-multiple-myeloma-ahead-of-adcomm/
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