GlaxoSmithKline Plc (GSK, GSK.L) said Tuesday that a Committee of the U.S. Food and Drug Administration has recommended approval of its cancer drug Votrient to treat advanced soft tissue sarcoma.
The FDA's Oncologic Drugs Advisory Committee, or ODAC, voted 11 to 2, stating that study results support a favorable benefit - risk profile for Votrient in treating patients with advanced soft tissue sarcoma who received prior chemotherapy.
The ODAC noted that those with gastrointestinal stromal tumours and adipocytic sarcomas were not included in the Phase III trial.
The ODAC provides FDA with independent expert advice and recommendations, however the final decision regarding approval is made by FDA.
Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body. Current treatment options for the disease include surgery, chemotherapy, radiation therapy, immunotherapy, and vaccine therapy.
According to the National Cancer Institute, annually about 11,000 cases of soft tissue sarcomas are diagnosed.
GlaxoSmithKline's Votrient is an orally administered drug that is currently approved in the U.S. to treat advanced kidney cancer. In the company's fourth quarter, the drug registered total sales of 31 million pounds. Apart from the U.S., GlaxoSmithKline has also filed an European application for Votrient.
Commenting on the FDA panel decision, Rafael Amado, senior vice president, GlaxoSmithKline Oncology, said, "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."
In the clinical study, Votrient was shown to temporarily slow cancer growth, while the FDA questioned the drug's efficacy in prolonging longevity. Results from a study revealed that those taking Votrient had a median progression-free survival of 4.6 months, compared to 1.6 months on the placebo.
On the flip side, a higher number of patients taking Votrient suffered serious adverse effects, compared to those on placebo, and this included blood clots in the lungs and heart dysfunction. Nonetheless, the drug found favor with panel members due to the limited options available to treat soft tissue sarcoma.
GSK is trading at $45.55, up $0.06 or 0.13%, on a volume of 1.0 million shares on the NYSE. GSK.L closed Tuesday on the LSE at 1,430 pence.
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