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Since the last few years there have a lot of developments in the orphan drug industry. The technological advancements have helped pharmaceutical companies to develop drugs for the treatment of rare diseases. Oncology is the therapeutic area for which the maximum numbers of orphan drugs are being developed by the pharmaceutical companies. Regulatory authorities such as the FDA have also approved many orphan drugs recently for the treatment of various forms of cancer. For instance, in November 2015, Cellceutix received orphan drug designation from the USFDA for Kevetrin. This drug will be used for the treatment of retinoblastoma, a rare form of eye cancer that begins in the retina of the eye. Retinoblastoma is most generally found in children, usually before the age of three, and rarely found in adults. It is sight threatening and potentially fatal if not diagnosed early.
 
Similarly, in July 2015, the USFDA also granted orphan drug designation to an immunotherapy known as DPX-Survivac. This biological therapy is in development for the treatment of ovarian cancer. This drug has produced some positive phase I results and is also being tested in recurrent diffuse large B-cell lymphoma. Moreover, positive opinion for orphan drug designation has been granted to Avelumab by European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP). This drug has been manufactured by Merck and Pfizer. The COMP positive opinion is for the cancer immunotherapy avelumab, for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. Another investigational compound, ABT-414, has received EMA and FDA orphan Drug Designation for the treatment of glioblastoma multiforme. ABT-414 is an anti-epidermal growth factor receptor antibody drug conjugate which is being developed by AbbVie. The orphan drug designation is an important regulatory advancement for the company as they further their development in recurrent glioblastoma multiforme, a disease that is uniformly fatal with limited treatment options. Such developments of orphan drugs in the oncology field have opened an array of opportunities for the treatment of various kinds of cancers.
 
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