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8 Oct 2012

Masitinib accepted for MAA review by European Medicines Agency

Clinical trials suggest Masitinib is more successful than current treatments for GIST patients resistant to Gleevec.

AB Science has announced the acceptance for review its Marketing Authorisation Application (MAA) for masitinib for treatment of patients with Gleevec-resistant gastro-intestinal stromal tumours (GIST).

The application was filed with the European Medicines Agency, which accepted it based on results from a phase II study that indicated the drug can significantly improve survival rates among these patients, when compared to a competing drug.

The study consisted of 44 patients with inoperable, locally advanced or metastatic GIST whose diseases had continued to progress despite treatment with Gleevec.

They were split into two groups, the first of which received 12mg/kg a day of masitinib, while the rest received sunitinib at 50mg/day.

Overall survivability stood at 95.7 per cent, 81.9 per cent and 81.9 per cent respectively for the first group at six, 12 and 18 months respectively. For the second group, the figures stood at 76.2 per cent, 57.1 per cent and 42.3 per cent.

AB Science chief executive Alain Moussy said: "The acceptance of this Marketing Authorisation Application by EMA shows that authorities consider masitinib as a potential candidate for registration in this refractory cancer, despite the small size of the phase 2 study."

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