The Glivec submissions are based on data from a Phase III, double-blind, randomized, multicenter, international study of more than 700 gastrointestinal stromal tumor (GIST) patients who had surgery to remove their tumors. The results showed a dramatic 89% reduction in risk of GIST returning after surgery (adjuvant setting) in patients treated with Glivec versus placebo, said Novartis.
The FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from 10 to six months. Similar regulatory submissions have been filed in the European Union (EU) and Switzerland and will be filed in other countries shortly.
Glivec is currently indicated in both the US and the EU for the first-line treatment of metastatic or unresectable (inoperable) kit-positive GIST. If approved, the use of Glivec for the treatment of GIST in the adjuvant setting would add to its eight current indications, which include Philadelphia chromosome-positive chronic myelogenous leukemia and five other rare diseases.