Dáil Éireann Debate, Wednesday - 18 October 2017
131. Deputy Jack Chambers asked the Minister for Health if he will request the Health Products Regulatory Authority to license pembrolizumab for use in the treatment of fine cell neuroendocrine rectal cancer; and if he will make a statement on the matter. [44084/17]
View answerPembrolizumab is authorised for the treatment of a number of cancers, including melanoma, non-small cell lung cancer and Hodgkin lymphoma. These authorisations were issued by the European Commission, following a recommendation from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA). The Health Products Regulatory Authority is a member of this committee.
Pembrolizumab is not currently authorised for fine cell neuroendocrine rectal cancer. In order to achieve this clinical indication, the company marketing pembrolizumab would need to submit data to the EMA for review by the CHMP. If the data were supportive of the safety and efficacy of pembrolizumab in this indication, an amended authorisation could be issued by the European Commission.
It is important to note that the Minister for Health has no role in the authorisation process for medicines in Ireland.
