FDA approves Pfizer drug in two cancer indications

This is the first time the agency has approved a new oncology product for two indications simultaneously.

Sutent, which received a priority review and was approved in less than six months, is a tyrosine kinase inhibitor working through multiple targets to deprive the tumor cells of the blood and nutrients needed to grow.

“Today’s approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer” said Dr Steven Galson, director of FDA’s Center for Drug Evaluation and Research. “New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives.”

According to the American Cancer Society, about 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year.

In gastrointestinal stromal tumors (GIST), Sutent was shown to increase the median time to tumor progression to 27 weeks compared with six weeks for patients who were not treated. In this indication the drug was approved for the treatment of patients with whose disease has progressed or who are unable to tolerate treatment with Novartis’ Gleevec, the current standard treatment for GIST patients.

The approval for the drug in advanced renal cell carcinoma (kidney cancer), was based on the drugs ability to reduce the size of the tumors in patients. An overall response rate ranging from 26-37% was found in patients with metastatic kidney cancer whose tumors had progressed following cytokine-based therapy.