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ODAC supports approval of sarcoma drug
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An FDA panel overwhelmingly expressed its support for the approval of pazopanib for patients with advanced soft tissue sarcoma who previously underwent chemotherapy.
The Oncologic Drugs Advisory Committee voted 11-2 in favor of GlaxoSmithKline’s supplementary application for pazopanib (Votrient), basing its decision on results of two studies — one Phase 3 and another Phase 2 — that showed the drug extended PFS by an average of 3 months compared with placebo.
After 1 year, study results showed OS for patients treated with pazopanib was 12.6 months, compared with 10.7 months who received chemotherapy, the standard treatment for sarcoma.
Patients assigned to pazopanib experienced higher rates of some adverse events — including fatigue, decreased appetite and vomiting — compared with those treated with chemotherapy. Other side effects associated with pazopanib included high blood pressure, heart problems and liver toxicity.
“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,” Rafael Amado, senior vice president of GlaxoSmithKline Oncology, said in a press release. “We look forward to continuing the regulatory process.”
The FDA often follows the advisory committee’s recommendations but is not obligated to do so.
The FDA approved pazopanib in 2009 as a treatment for patients with advanced renal cell carcinoma.