The US FDA has accepted for review an investigational new drug application for oral administration of palifosfamide (Zymafos®), a novel DNA cross-linker in the same class as bendamustine, ifosfamide, and cyclophosphamide. An intravenous (IV) form of the drug is currently being evaluated in a Phase III study for the treatment of metastatic soft tissue sarcoma in the front-line setting (PICASSO 3) and is entering an adaptive Phase III trial in extensive small cell lung cancer, expected to initiate in the second half of 2012. A clinical study with the oral form, tested pre-clinically in multiple tumour types, is expected to follow.