It is worthy of note that FDA has just granted “breakthrough therapy” to an investigational drug called bimagrumab for the treatment of a rare muscle-wasting disease known as sporadic inclusion body myositis or sIBM, based on data from a Phase II proof-of-concept study that has shown a substantial benefit for patients treated with bimagrumab compared to placebo.
So why is this worthy of note for the prostate cancer community?
Because bimagrumab is also in clinical development for the treatment of cancer-related cachexia, a wasting syndrome that is associated with loss of weight, muscle atrophy, fatigue, weakness, and significant loss of appetite in people who is not actively trying to lose weight. Cachexia is commonly observed in patients with advanced forms of cancer who are undergoing or have undergone chemotherapy. As yet, however, there do not appear to be any clinical trials of BMY338 in the management of cachexia, so we will need to temper enthusiasm until the developer is able to demonstrate proof of concept in that condition too.
To see Novartis’s media release about the breakthrough designation, please click here. The results of this study showing the efficacy of bimagrumab in sIBM will be presented at the annual meeting of the American Neurological Association upcoming on October 14.
There are no really effective treatments available at this time for the treatment of either sIBM or cancer-related cachexia.