AB Science files pancreatic cancer candidate masitinib with EMA

17 October 2012

France-based AB Science SA (NYSE Euronext - FR0010557264 - AB) has confirmed the filing of a Marketing Authorization Application for masitinib in the treatment of pancreatic cancer with the European Medicines Agency.

AB Science said that the communication of the results was delayed to allow the filing for patent applications aiming at extending the period of marketing exclusivity of masitinib in case of commercialization in this indication. Masitinib has received orphan drug designation in the treatment of gastrointestinal stromal tumors GIST) from both the US Food and Drug Administration and the EMA.

Early this year, AB Science announced encouraging results from a Phase II study with its investigational drug, masitinib, in Gleevec (imatinib)-resistant GIST (The Pharma Letter February 6). Masitinib, which is already sold by the company as a treatment for a common form of cancer in dogs, significantly improved overall survival in patients with Gleevec-resistant GIST compared to Sutent (sunitinib) from global drugs behemoth Pfizer, a drug approved for second-line treatment of GIST, currently the standard of care for these patients

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