Wednesday, 29 May 2019

Questions (104)

Louise O'Reilly


104. Deputy Louise O'Reilly asked the Minister for Health if pembrolizumab has received marketing authorisation here and in the EU, respectively, for the treatment of cervical and colorectal cancer. [22941/19]

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Written answers (Question to Health)

I wish to advise the Deputy that pembrolizumab has marketing authorisation in Ireland and the EU for a number of indications and is reimbursed by the HSE for some of those indications. However, pembrolizumab does not have marketing authorisation in Ireland or the EU for the treatment of cervical or colorectal cancer.

It should be noted clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications, which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received.