Regulation of immunotherapeutic products for cancer and FDA’s role in product development and clinical evaluation
Abstract
分类： 一般
CAR T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers
For years, the cornerstones of cancer treatment have been surgery, chemotherapy, and radiation therapy. Over the last decade, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®)—drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also emerged as standard treatments for a number of cancers.
FDA letter: Lymphocyte Immune Therapy (LIT) Letter
Department of Health and Human Services
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
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https://www.bio.org/articles/how-do-drugs-and-biologics-differ
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