Novartis has received a positive opinion supporting EU approval of Glivec as a post-surgery treatment for patients at significant risk of relapse following removal of gastrointestinal stromal tumors.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Glivec based on positive findings from a pivotal Phase III study, which showed that use of Glivec after surgery reduces risk of recurrence by approximately 89%.
The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months. The decision will apply in all 27 EU member states plus Iceland and Norway.
The double-blind, randomized, multicenter study was conducted throughout the US and Canada. It included 713 GIST patients whose tumors had been surgically removed. The study compared the recurrence-free survival (RFS) of patients taking either Glivec 400 mg daily or placebo immediately following surgery. The results showed that 98% of those receiving Glivec remained recurrence-free one year following surgery compared with approximately 83% of those receiving placebo (P<0.0001).
The investigators reported that Glivec therapy was well tolerated by most patients, with side effects similar to those observed in previous clinical trials with Glivec. These include nausea, diarrhea and swelling (edema).
David Epstein, president and CEO of Novartis Oncology, said: This positive opinion is an important step forward for gastrointestinal stromal tumors patients. If approved in Europe, Glivec would provide an immediate option for post-surgical protection against the return of this highly aggressive disease.