The Junovan new drug submission includes efficacy and safety data from a phase III trial of the bone cancer known as osteosarcoma. The trial was conducted by the Pediatric Oncology Group and the Children’s Oncology Group.
“This is a bone cancer that generally metastasizes to the lung and affects mainly children and young adults. At IDM, we are very pleased to submit Junovan to the FDA with the hope of improving the outcome of these young patients for whom very few new therapeutic options have been made available over the last two decades,” stated Jean-Loup Romet-Lemonne, CEO of IDM.
IDM requested that the FDA consider granting this new drug application priority review status, which could shorten review time from the standard ten months to six months if granted. The FDA and the European Medicines Evaluation Agency have designated orphan drug status to Junovan.