FDA panel backs GlaxoSmithKline sarcoma drug Votrient

Providing welcome news for UK pharma giant GlaxoSmithKline (LSE: GSK), the Oncologic Drugs Advisory Committee (ODAC) to the US Food and Drug Administration voted 11 to two that evidence from clinical studies support a favorable benefit–risk assessment for use of Votrient (pazopanib) in treating patients with advanced soft tissue sarcoma who have received prior chemotherapy, noting that those with gastrointestinal stromal tumors (GIST) and adipocytic sarcomas were not included in the Phase III trial.

The ODAC yesterday reviewed findings from one Phase III clinical study and one Phase II trial. These showed that patients who received Votrient survived three months longer on average, without disease progression, compared with subjects who received a placebo. However, after a year, the data showed no statistically significant improvement in overall survival rates.

Although Votrient is not approved in the USA or Europe for the treatment of advanced soft tissue sarcoma, a relatively rare form of cancer, it is cleared for advanced renal cell carcinoma. A final decision from the FDA itself is scheduled for May 6).