With great excitement, the International Society for Cell & Therapy (ISCT) publishes its third bi-annual Global Regulatory Report in collaboration with Citeline. Similar to the previous editions, this report offers a comprehensive global overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products (Cell, Genetically-Modified Cell, and Gene Therapies).
Highlights from this issue include:
- Beqvez™, a one-time gene therapy for adults with Hemophilia B, has received its approval from EMA, Health Canada, and US FDA
- Amtagvi™, the first cellular therapy to treat patients with unresectable or metastatic melanoma, has been approved by US FDA
- Zevor-cel (CT-053), CAR-T cell therapy for relapsed or refractory multiple myeloma, received its approval from NMPA
- Public consultation of US FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products
This report reveals that H1 2024 was a period of growth, particularly for non-genetically modified cell therapies:
- There has been a 4% increase in the number of non-genetically modified cell therapies in the pipeline compared to H2 2023.
- The non-genetically modified cell category remains dominant, with 46 therapies in Phase III or pre-registration phases as of H1 2024.
- Non-genetically modified cell therapies continue to comprise the majority of all approved products, representing 68% of the total.
Bambi Grilley, ISCT Chief Regulatory Officer, remarked, "It is noteworthy that among all categories, non-genetically modified cells continue to dominate, with most therapies in Phase III or pre-registration stages, and they constitute the majority of approved products. I am eager to understand the implications for the field and to anticipate developments in the coming months, particularly in light of the evolving global legislative and regulatory framework".
Join us in celebrating the release of this new edition. [Click here to access the full report]
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