The FDA is investigating reports of new cancer developments in patients treated with CAR-T cell immunotherapies, specifically targeting BCMA or CD19. This probe, announced on a recent Tuesday, follows cases from clinical trials and postmarketing surveillance where patients developed T-cell malignancies, including CAR-positive lymphoma. Some of these cases resulted in hospitalization or death. The FDA’s concern extends to all approved CAR-T therapies, as the risk seems to be present across various products.

Currently, the market has several CD19 CAR-T therapies like Yescarta, Tecartus, Kymriah, and Breyanzi, and BCMA therapies such as Carvykti. Incidents of T-cell lymphoma have been reported for several of these products. Despite this, companies like Gilead Sciences and Novartis express confidence in their products, citing a lack of evidence directly linking their therapies to new malignancies. Gilead has treated 17,700 patients without any clear causal relationship. Similarly, Novartis, with over 10,000 patients treated with Kymriah, denies a causal link.

Legend Biotech points out that T-cell malignancies can occur in multiple myeloma patients even without CAR-T treatments, and Johnson & Johnson, makers of Carvykti, have reported a favorable benefit-risk profile from their surveillance data. These companies are cooperating with the FDA, providing data and analyses as the agency considers potential regulatory actions. The risk of developing secondary cancer is already included as a class warning on CAR-T therapy labels.

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.

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