GSK Receives Positive Vote from FDA on Votrient for Soft Tissue Sarcoma
(Chemotherapy Advisor) – GlaxoSmithKline announced on March 20 that the Oncologic Drugs Advisory Committee (ODAC) to the U.S. Food and Drug Administration voted 11 to 2 that there was sufficient clinical evidence and a favorable benefit-risk assessment for use of Votrient (pazopanib) in treating patients with advanced soft-tissue sarcoma who have received prior chemotherapy. Gastrointestinal stromal tumors (GIST) and adipocytic sarcomas were not included in this Phase 3 trial.
The ODAC reviewed data from one Phase 2 and one Phase 3 trial. ODAC is charged with providing the FDA with independent advice and recommendations, but approval of the drug ultimately falls to the FDA. Votrient is currently indicated for the treatment of renal cell carcinoma in the United States, United Kingdom, and European Union, but not approved or licensed in the United States or European Union for the treatment of advanced soft-tissue sarcoma.
"Treatment options for patients with advanced soft-tissue sarcoma are limited; we are therefore pleased that the Committee took a favorable view of the clinical data for Votrient," said Rafael Amado, Senior Vice President, GlaxoSmithKline Oncology. "We look forward to continuing the regulatory process."