"5. BENEFIT – RISK BALANCE Benefits:
Based on the field study, a modest postponement of the time until the mast cell tumour progresses (TTP) of approximately 40 days could be demonstrated in the overall study population as compared to placebo. A retrospective subgroup-analysis of the field study indicated that this effect might be due to a small sub-population of dogs with mutated c-Kit.
Treatment is connected with a significant risk for occurrence of adverse events of a similar character as disease symptoms. In addition, CVMP considered that treatment did not reduce the need for supportive co-medication and that the ability to provide necessary analgetic/anti-inflammatory treatment may be jeopardised due to occurrence of treatment related gastrointestinal events. Thus, treatment is likely to be associated with a reduction rather than a maintenance or improvement of the dogs ́ life quality.
There is limited information available of the metabolic pathway, which is of concern because of the potential for drug-drug interactions, which are common in tumour patients that often receive concomitant treatment with other medicines.
In humans, masitinib is a strong skin sensitiser and a severe eye irritant. Reduced female fertility and embryotoxicity was observed in laboratory animals and there are concerns in regard to female fertility. Following oral administration of masitinib, gastrointestinal reactions and changes in laboratory parameters have been reported in people. Accidental oral ingestion by a child is considered a potential risk because of the low margin of safety; however, attention was given in the product development to user safety by providing the product as film-coated tablets and with a child-proof container.
A number of risks highlighted above might be addressed / managed by appropriate warnings in the product literature (e.g. user safety).
However, satisfactory benefits of treatment for the entire proposed population have not been demonstrated and significant risks for the treated animals, constituted by potentially long lasting adverse events, are expected and this is not acceptable in view of an intended life-long treatment.
Thus the benefit-risk-balance was considered negative."
Yes I see several studies, still need to look deeper. Some are old studies that say its beneficial other say not, but I would imagine if the oct is inoperable it may be better than nothing. The dates I find are from 2008-2011 still looking for more updated info. I am also looking at the benedryl/tagament, a lot of people seem to like that. Personally I am happy that at present I do not need to deal with it. Just hoping I can find more info for others.