Cell-based therapies in oncology represent a transformative approach to cancer treatment. By leveraging the power of living cells often from the patient’s own immune system — these therapies are designed to precisely target and eliminate cancer cells. Notable examples include chimeric antigen receptor (CAR) T cell therapy, where a patient’s T cells (a type of immune cell) are genetically modified to recogniz and attack cancer; tumor-infiltrating lymphocyte (TIL) therapy, , where immune cells from the tumor are expanded and reinfused; and natural killer (NK) cell therapies, which harness another potent immune cell type to destroy cancer cells.
As these therapies evolve, understanding the complex regulatory environment becomes essential for ensuring timely patient access to safe and effective treatments. This blog explores the major regulatory pathways that support the development and approval of cell-based oncology therapies across key global markets.
The Regulatory Framework for Cell-Based Therapies
Given their complexity and potential, cell-based therapies are subject to stringent regulatory scrutiny. Regulatory authorities worldwide have developed specialized frameworks and expedited pathways to balance innovation with safety, quality, and efficacy especially for therapies targeting serious or life-threatening conditions.
Read more in detail here: https://resource.ddregpharma.com/blogs/regulatory-pathways-for-cell-based-therapies-in-oncology/
