Regulation of biologic oncology products in the FDA׳s Center for Biologics Evaluation and Research.

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.

Regulation of immunotherapeutic products for cancer and FDA's role in product development and clinical evaluation.

Immunotherapeutics include drugs and biologics that render therapeutic benefit by harnessing the power of the immune system. The promise of immune-mediated therapies is target specificity with a consequent reduction in off-target side effects. Recent scientific advances have led to clinical trials of both active and passive immunotherapeutic products that have the potential to convert life-ending diseases into chronic but manageable conditions.

Velcade: U.S. FDA approval for the treatment of multiple myeloma progressing on prior therapy.

Bortezomib (formerly PS-341), a promising new drug for the treatment of multiple myeloma, recently received accelerated approval from the U.S. Food and Drug Administration (FDA) for the therapy of patients with progressive myeloma after previous treatment.

Fulvestrant in postmenopausal women with advanced breast cancer.

Purpose: Patients with hormone-sensitive breast cancer who have responded to tamoxifen (TAM) may receive additional benefit from a second endocrine agent after progression or relapse after TAM therapy. Fulvestrant (FVT; Faslodex; i.m.