The Saforis new drug application is partially based on a pivotal phase III trial which was completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens.
The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met. Data indicated that patients receiving Saforis experienced a 22% relative risk reduction of clinically significant oral mucositis compared with placebo.
“More than 200,000 patients undergoing mucotoxic cancer therapy in the US develop significant oral mucositis each year,” said Lonnie Moulder, president and CEO of MGI Pharma. “We look forward to working closely with the FDA during the review process in order to bring this important supportive care product to cancer patients.”