Novartis announced that Glivec (imatinib) has been granted priority review status by the US Food and Drug Administration (FDA) as the first therapy to be reviewed for use after surgery in kit-positive gastrointestinal stromal tumours (GIST). FDA priority review status is granted to therapies that could potentially fill a currently unmet medical need and accelerates the standard review timing from ten to six months. Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly.

The Glivec submissions are based on data from a phase III, double-blind, randomized, multicentre, international study of more than 700 GIST patients who had surgery to remove their tumours. The results showed a dramatic 89 per cent reduction in risk of GIST returning after surgery (adjuvant setting) in patients treated with Glivec versus placebo.

In early 2007, the study met its primary efficacy endpoint, showing an advantage for Glivec in recurrence-free survival. At that time, following the recommendation of the independent study data monitoring committee to stop the trial accrual early, the study investigators made public the interim results and offered Glivec to patients receiving placebo.

Approximately half of all patients with newly diagnosed GIST are considered candidates for surgical resection, or removal of their tumours. Of those who have the surgery, about half will suffer a recurrence. If approved for this indication, Glivec will be the first treatment option available to GIST patients after surgery to reduce the risk of disease recurrence or to possibly prevent the disease from returning.

"FDA priority review status acknowledges the potential for Glivec to become the first post-surgery treatment available to GIST patients and may soon create a fundamental shift in the treatment of this disease," said Herve Hoppenot, executive vice president, chief commercial officer, Novartis Oncology.

Glivec is currently indicated in both the US and 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 leukaemia (Ph+ CML) and five other rare diseases. Novartis also has a therapy for the treatment for carcinoid tumours and acromegaly and multiple treatments in the pipeline targeting rare diseases.

Glivec is approved in more than 90 countries, including the US, EU and Japan, for the treatment of all phases of Ph+ CML. Glivec is also approved in the EU, US and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In Japan, Glivec is approved for the treatment of patients with Kit (CD117)-positive GIST. In the EU, Glivec is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukaemia (HES/CEL).

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