The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Votrient (pazopanib) for the treatment of the rare cancer advanced soft tissue sarcoma. Patients who were already administered chemotherapy will be eligible for pazopanib if the FDA (Food and Drug Administration) goes along with the Committee’s recommendation. The FDA is under no obligation to do what the Committee advises, but it nearly always does.

ODAC voted 11 to 2 that, according to evidence its experts examined from clinical studies, the benefit-risk assessment for pazopanib is favorable – in other words, the drug’s benefits for specific patients far outweigh the risks.

ODAC examined the results of pazopanib Phase III and Phase II human trials. The Committee noted that the Phase III study did not include patients with gastrointestinal stromal tumors and adipocytic sarcomas.

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 favourable view of the clinical data for Votrient. We look forward to continuing the regulatory process.”

Votrient is approved by the FDA for the treatment of renal cell carcinoma. It is a powerful and selective multi-targeted receptor tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-a/β. It blocks tumor growth and stops the formation of new blood vessels that feed the tumor (effectively starving it of nutrients).

This is a malignant tumor that starts in blood vessels, fibrous tissue, fat, muscle, synovial tissues (the lining of the joints) or other “soft” tissues in the body. This kind of cancer does not originate in the cartilage or bone.

Soft tissue sarcomas are rare. However, when they do occur they tend to be serious and are frequently diagnosed when the disease is already in its advanced stage.

There are several types of soft tissue sarcoma. Patients tend to have similar signs and symptoms and treatments are also similar.

Written by Christian Nordqvist