Astellas’ CDI drug may protect cancer patients

 Astellas’ oral antibiotic Dificlir may help to treat C. difficile infections (CDI) in cancer patients receiving chemotherapy, according to new studies.

Dificlir (fidaxomycin) may offer this patient group better prospects of clinical cure and sustained clinical cure with less risk of recurrence than vancomycin, the current standard treatment for CDI.

Cancer patients are particularly at risk of CDI due to their long hospital stays and the negative impact of chemotherapy on immunity.

A recent phase III trial showed Dificlir to be more effective than vancomycin in preventing recurrence of CDI, a major issue in treatment of the dangerous ‘superbug’.

Post-hoc analysis of data from that and another trial focused on 183 patients with CDI who had a current diagnosis of cancer. This sub-group showed higher rates of clinical cure (97.3% versus 87.5%) and sustained clinical cure (83.6% versus 61.3%) as well as reduced rates of recurrence (14.1% versus 30.0%) when treated with Dificlir rather than vancomycin.

Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne, Germany, commented: “Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling pre-existing conditions. Treatment options that reduce the burden of CDI, and in particular recurrence, will allow clinicians to focus their efforts on treating the cancer.”

“Results from key Phase III trials and the post-hoc analysis demonstrate the effectiveness of Dificlir as a novel and effective treatment in patients with CDI, but also in high-risk populations, such as patients with cancer,” said Ken Jones, CEO of Astellas Pharma Europe.

Dificlir, first developed by Optimer Pharmaceuticals, is exclusively licensed to Astellas Pharma Europe for development and commercialisation in Europe.

UK-based Astellas Pharma Europe is a subsidiary of Tokyo-based company Astellas Pharma.