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FDA approves Novartis drug Gleevec® label recommending extending treatment to three years for certain GIST patients after surgery
Date:2/1/2012

s to recommend consideration of at least three years of adjuvant therapy with Gleevec for patients with high-risk GIST(2).

In addition to extending the Gleevec label to three-year treatment duration in patients with KIT+ GIST after surgery, the FDA has agreed that all accelerated post-approval commitments for this indication have been met, confirming the clinical benefit of adjuvant treatment with Gleevec.

Study details
The SSG XVIII clinical trial was conducted by the Scandinavian Sarcoma Group (SSG) and the Sarcoma Group of the Arbeitsgemeinschaft Internistische Onkologie (AIO). This trial was a multicenter, prospective, randomized study for the evaluation of adjuvant treatment with Gleevec of histologically confirmed KIT+ GIST(5).

The primary endpoint of the study was to compare, within the first five years, recurrence-free survival in patients with a greater than 50% estimated risk of GIST disease recurrence, following diagnosis and treatment with adjuvant Gleevec for either 12 or 36 months. The secondary endpoints included overall survival and treatment safety(1).

Three hundred ninety-seven patients entered the study. Inclusion criteria for risk of recurrence was defined as tumor diameter >5.0 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.

Recurrence-free survival was longer in the 36-month group compared to the 12-month group (HR 0.46, 95% CI 0.32-0.65; p<0.0001). Patients assigned to 36 months of Gleevec after surgery had longer overall survival (HR 0.45, 95% CI 0.22-0.89; p=0.0187). Almost all patients experienced side effects while taking Gleevec. Gleevec was generally well tolerated. The proportion of patients who discontinued Gleevec during the assigned treatment period for reasons other than GIST recurrence was 26% over the full three yea
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