The FDA has postponed its decision on approving Bristol Myers Squibb and 2seventy bio’s CAR-T cell therapy for multiple myeloma in earlier treatment lines. Originally expected by December 16, the decision’s delay is due to the FDA’s plan to convene a public meeting with external experts. Currently, Abecma, the CAR-T therapy, is approved for patients who have undergone four or more prior treatments, but Bristol Myers and 2seventy bio sought approval for patients who had received two to four prior regimens.

The FDA’s emphasis on considering overall survival data, rather than just progression-free survival, is evident in its recent actions. The delay poses challenges for Abecma, as the therapy’s use has slowed with the approval of alternative multiple myeloma treatments, such as Carvykti. Moreover, Abecma’s Phase III study indicated a slightly higher death rate in the Abecma arm compared to standard care.

The delay is detrimental to 2seventy bio, which previously laid off 40% of its staff due to lower-than-expected Abecma sales. This setback caused a significant drop in the biotech company’s shares, which were already down 81% for the year.

About PackGene

PackGene is a CRO & CDMO technology company that specializes in packaging recombinant adeno-associated virus (rAAV) vectors. Since its establishment in 2014, PackGene has been a leader in the AAV vector CRO service field, providing tens of thousands of custom batches of AAV samples to customers in over 20 countries. PackGene offers a one-stop CMC solution for the early development, pre-clinical development, clinical trials, and drug approval of rAAV vector drugs for cell and gene therapy (CGT) companies that is fast, cost-effective, high-quality, and scalable. Additionally, the company provides compliant services for the GMP-scale production of AAVs and plasmids for pharmaceutical companies, utilizing five technology platforms, including the π-Alpha 293 cell AAV high-yield platform and the π-Omega plasmid high-yield platform. PackGene's mission is to make gene therapy affordable and accelerate the launch of innovative gene drugs. The company aims to simplify the challenging aspects of gene therapy development and industrialization processes and provide stable, efficient, and economical rAAV Fast Services to accelerate gene and cell therapy development efforts from discovery phase to commercialization.

Related News