title: Regulation of biologic oncology products in the FDA׳s Center for Biologics Evaluation and Research.
abstract: In the United States, cancer vaccines and immunotherapies, including cell and gene therapies and peptides and proteins used as therapeutic vaccines, are regulated by the Food and Drug Administration's Center for Biologics Evaluation and Research in the Office of Cellular, Tissue, and Gene Therapies (OCTGT). Center for Biologics Evaluation and Research has licensed two immunotherapy products for urologic indications: bacillus Calmette-Guérin for superficial bladder cancer and sipuleucel-T for advanced prostate cancer. OCTGT places a high priority on scientific and regulatory activities that promote the development of safe and effective cancer therapy products. OCTGT has published guidance documents and developed innovative tools that are designed to aid the rapid development of biologic products for patient use. The success of immunotherapeutic products for urologic malignancies stands as an example for ongoing and future therapeutic research and discovery.
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Bross
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD.
authors.forename: Chaohong
authors.initials: C
authors.lastname: Fan
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD.
authors.forename: Bindu
authors.initials: B
authors.lastname: George
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD.
authors.forename: Kevin
authors.initials: K
authors.lastname: Shannon
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD.
authors.forename: Bharat H
authors.initials: BH
authors.lastname: Joshi
authors.affiliation: Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration, Silver Spring, MD. Electronic address: raj.puri@fda.hhs.gov.
authors.forename: Raj K
authors.initials: RK
authors.lastname: Puri
mesh_terms: D001688:Biological Products / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D015316:Genetic Therapy; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D008495:Medical Oncology / Q000379:methods*; D011471:Prostatic Neoplasms / Q000628:therapy*; D014020:Tissue Extracts / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration; D001749:Urinary Bladder Neoplasms / Q000628:therapy
chemical_list: D001688:Biological Products; D014020:Tissue Extracts; C511774:sipuleucel-T
keywords: Bladder cancer; Cancer vaccines; Cell therapy; FDA; Gene therapy; Immunotherapy; Oncology; Prostate cancer; regulation