European Commission approves new label for Novartis drug Glivec® extending adjuvant therapy to three years for certain GIST patients

Novartis announced today that the European Commission (EC) has approved an update to the Glivec® (imatinib)* label to include 36 months of treatment after surgery for adults with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the inclusion criteria of the pivotal study. End Quote

(1888PressRelease) February 27, 2012 - This extended treatment regimen has been shown to improve recurrence-free survival and overall survival for these patients with KIT+ GIST compared to patients who received 12 months of treatment after surgery[3].

Adults with KIT+ GIST are at risk of recurrence following surgical removal of the primary tumor. Although complete surgical removal is possible in most patients with KIT+ GIST, many patients develop tumor recurrence or metastasis following surgery and survival following recurrence is poor[2]. The newly updated label states that treatment with Glivec beyond 36 months may delay the onset of tumor recurrences further, while noting that an effect on overall survival has not been determined.

The EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and applies in all 27 European Union (EU) member states, plus Norway and Iceland. Approval was based on data from an international, multicenter, open-label, Phase III clinical trial first presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) plenary session in June 2011[1].

Results of the study showed that at five years, 66% of patients taking Glivec for three years after surgery for KIT+ GIST remained free of cancer recurrence compared to 48% who had received Glivec for only one year after surgery (p5.0 cm and mitotic count >5/50 high power fields (HPFs); or tumor diameter >10.0 cm, any mitotic count; or tumor of any size with a mitotic count >10/50 HPFs; or tumors ruptured into the peritoneal cavity.

Three hundred ninety-seven patients entered the study and the median follow-up was 54 months, from date of randomization to data cut-off. Recurrence-free survival was significantly longer in the 36-month group compared to the 12-month group (HR 0.46, 95% CI 0.32-0.65; p

###

space

Other Related Press Releases