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UPDATE 1-Novartis' Glivec gets FDA priority review

Wed Aug 27, 2008 2:24am EDT

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ZURICH, Aug 27 (Reuters) - Novartis's (NOVN.VX) Glivec has received U.S. regulator priority review as the first therapy to reduce the recurrence of gastrointestinal stromal tumours after surgery, the Swiss drugmaker said on Wednesday.

Clinical data showed an 89 percent reduction in the risk of gastrointestinal stromal tumours (GIST) after surgery when the cancer treatment Glivec was used, Novartis said in a statement.

Food and Drug Administration priority review status is granted to therapies that could potentially fill an unmet medical need and accelerate the standard review timing from six months to 10 months, Novartis said.

Similar regulatory submissions have been filed in the European Union and Switzerland and will be filed in other countries shortly, the group said.

"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," Herve Hoppenot, executive vice president, chief commercial officer, Novartis Oncology.

The Glivec submissions are based on data from a Phase III study of more than 700 GIST patients who had surgery to remove their tumours.

Glivec is indicated in both the US and EU for the first-line treatment of metastatic or inoperable kit-positive GIST, the group said.

If approved, the use of Glivec for the treatment of GIST in the adjuvant setting would add to its eight current indications, Novartis said. (Reporting by Katie Reid; editing by Sue Thomas)



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