FDA Approval Summary: Vorinostat for Treatment of Advanced Primary Cutaneous T-Cell Lymphoma
United States Food and Drug Administration · Center for Drug Evaluation and Research
Abstract
On October 6, 2006, the U.S. Food and Drug Administration granted regular approval to vorinostat (Zolinza(R); Merck & Co., Inc., Whitehouse Station, NJ), a histone deacetylase inhibitor, for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. The pivotal study supporting approval was a single-arm open-label phase II trial that enrolled 74 patients with stage IB and higher CTCL who had failed two systemic therapies (one of which must have contained bexarotene). Patients received vorinostat at a dose of 400 mg orally once daily, which could be reduced for toxicity to 300 mg daily or…
Citation impact
- FWCI
- 18.16
- Percentile
- 100%
- References
- 21
Authors
5- BMBhupinder MannCorresponding
United States Food and Drug Administration, Center for Drug Evaluation and Research
- JRJohn R. Johnson
United States Food and Drug Administration, Center for Drug Evaluation and Research
- MHMartin H. Cohen
United States Food and Drug Administration, Center for Drug Evaluation and Research
- RJRobert Justice
United States Food and Drug Administration, Center for Drug Evaluation and Research
- RPRichard Pazdur
United States Food and Drug Administration, Center for Drug Evaluation and Research
Topics & keywords
- Medicine
- Vorinostat
- Cutaneous T-cell lymphoma
- Lymphoma
- Oncology
- Mycosis fungoides
- Immunology