Oncept Melanoma: Withdrawal of the marketing authorisation application
On 24 April 2013, the applicant MERIAL submitted an application for a marketing authorisation to the European Medicines Agency (the Agency) for Oncept Melanoma in accordance with Regulation (EC) No. 726/2004.The eligibility to the centralised procedure was confirmed by the CVMP on 11–13 September 2012 falling within Article 3(1) of Regulation (EC) No 726/2004 as Oncept Melanoma is a product developed by a biotechnological process. The rapporteur appointed was A.-M. Brady and the co-rapporteur was F. Klein.The application has been submitted in accordance with the requirements under Article 12(3) of Directive 2001/82/EC, as amended.Oncept Melanoma is a vaccine for dogs, containing melanoma plasmid DNA (deoxyribonucleic acid) pINGhT which encodes the human tyrosinase antigen. The product was to be presented in single dose glass vials (0.4 ml) in outer packs of 1 vial or 4 vials. The vaccine was to be applied transdermally to dogs, using a recommended transdermal, needle-free, medical device.The applicant initially applied for the following indication: Active immunisation for extending post-surgical survival times of dogs with oral malignant melanoma without pulmonary metastasis, following surgical removal of the primary tumour and achievement of loco-regional disease control (negative local lymph nodes).On 17 July 2014, Merial withdrew the application at day 180 of the procedure. In its letter notifying the Agency of the withdrawal of application, the applicant stated the reason for the withdrawal: The company's additional investment in research and development required to answer the remaining issues is not justified.
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Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CVMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter. An assessment report is published when the application is withdrawn after the first stage of the CVMP's evaluation is completed ('day 120').