Novartis’ GIST Drug, Glivec, Receives European Commission Approval

Novartis announced earlier today that the European Commission has approved an update to their Glivec (imatinib) label to include 36 months of treatment after surgery, for adults with KIT (CD117)-positive gastrointestinal stromal tumours (GIST) who met the inclusion conditions of the pivotal study.

The prolonged treatment has been demonstrated to increase recurrence-free survival and the overall survival rate for patients with KIT+ GIST, in comparison to patients who received just 12 months of treatment post-surgery.

Adults with KIT+ GIST are at risk of relapse following the surgical removal of the primary tumour.  Although complete surgical removal is possible in the majority of patients with KIT+ GIST, many patients develop tumour recurrence or metastasis following surgery and survival after recurrence is poor.

The recently updated label notes that taking the drug, Glivec, beyond 36 months may delay the onset of tumour recurrences further, while pointing out that an effect on general survival has not been determined.

The approval from the European Commission follows a positive endorsement from the Committee for Medicinal Products for Human Use (CHMP), and applies in all 27 European Union member states, plus Norway and Iceland.

Authorisation was founded upon information from an international, multicenter, open-label, Phase III clinical trial initially presented at the 47th Annual Meeting of the American Society of Clinical.

The primary endpoint 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 Glivec for either 12 or 36 months.

The research study showed a significant increase in recurrence-free patients and in the overall survival rate after three years of taking Glivec.  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.  In addition, at five years, 92% of patients taking Glivec for three years after surgery were alive; compared to 82% who had received Glivec for only one year.

Nearly all the patients experienced side effects while taking Glivec, however the drug was generally well tolerated.  The proportion of patients who discontinued Glivec during the assigned treatment period for reasons other than GIST recurrence was 26% in the 36-month group and 13% in the 12-month group.

Hervé Hoppenot, President at Novartis Oncology, commented that the “approval marks a key milestone in advancing the post-surgical treatment of GIST for certain patients in Europe.”  “With this clinical evidence, physicians now have a strong basis for recommending three years of treatment for these patients with KIT+ GIST after surgery,” Hoppenot added.

Gastrointestinal stromal tumours are a rare, life-threatening cancer of the gastrointestinal tract.  They are frequently tough to diagnose and treat because they may not result in any physical symptoms.

Glivec is approved in over 110 countries worldwide for the treatment of all phases of Ph+ CML, for the treatment of adult patients with KIT (CD117)-positive gastrointestinal stromal tumours, which cannot be surgically removed and/or have metastasized and for the treatment of adult patients following complete surgical removal of KIT+ GIST.

Glivec is currently the only available therapy in the European Union for the treatment of post-surgical KIT+ GIST.  In the European Union, the incidence of GIST is estimated to be greater than 5,000 cases annually.


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