CHMP rejects Masican for GIST- AB Science
On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican (masitinib) from AB Science, intended for the treatment of malignant Gastrointestinal Stromal Tumour (GIST).One of the CHMP�s concerns was that the study was not designed to compare Masican to sunitinib and therefore it was difficult to interpret the results. Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking.
150 mins
Learning Zones
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