The European Medicines Agency (EMA) has recommended broadening the use of Johnson & Johnson (J&J) and Legend Biotech’s CAR-T therapy, Carvytki, to include earlier treatment stages for patients with relapsed or refractory multiple myeloma. This recommendation, based on positive data from the CARTITUDE-4 study, signifies a potential breakthrough in addressing the unmet medical needs of multiple myeloma patients in the European Union.

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.

Check out our AAV CDMO service to expedite your gene therapy research
About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.