The product under development obtained the orphan designation EMA (On 29 August 2016): cisplatin is a thin and flexible polymeric film, sufficiently resistant to be applied intrapleural or in other districts, adhering to the mesothelial or epithelial surfaces. Preclinical studies on rats showed that hyaluronate films loaded with cisplatin were significantly more effective in reducing tumour recurrence and assuring higher and prolonged plasmatic drug concentrations than cisplatin solution, without increasing systemic toxicity. Moreover, the protocol assistance, i.e. the list of experiments required to get the marketing authorisation, has already been discussed and approved by EMA.
