Cancer Therapy Using Nanoformulated Substances: Scientific, Regulatory and Financial Aspects

Several nanoformulated anti-cancer substances are currently commercialized or under development. Pre-clinical and clinical results have revealed better properties, that is, larger efficacy and lower toxicity for these substances than for conventional anti-cancer treatments. Here, we review the development of several of these substances such as Marqibo, Myocet, Doxil, DaunoXome, MM398, MM302, Mepact, Versamune, Thermodox, Depocyt, Livatag, Abraxane, Eligard, Opaxio, Zinostatin Stimalamer (SMANCS), Pegasys and PegIntron, BIND-014, CRLX-101, Oncaspar, Neulasta, Aurimmune, Auroshell, AuNPs, Nanotherm, NanoXray, Magnetosome chains, Kadcyla (T-DM1), Ontak (DAB/IL2), Gendicine and Curcumin. We describe their specific properties, such as their stability, solubility, mean of administration or targeting, distribution, metabolism and toxicity. We discuss their categorization as medical devices or drugs, their fabrication process within a regulatory environment as well as intellectual property and financial aspects that are all essential to enable their industrial development.