Following a recent audit sanctioned by the Department of Health and BNMS Council, a positive recommendation on Lutathera from the company AAA has been made. This document has been placed in a secure NHS website controlled by the NHS Pharmaceutical Quality Assurance committee.
NHS Clinicians and Radiopharmacies intending to purchase the product as an unlicensed pharmaceutical outside of the current clinical trial should contact either Paul Maltby (firstname.lastname@example.org) or Jilly Croasdale (email@example.com) in the first instance for further information. It is expected that compliance with the requirements for unlicensed products as outlined in the QA of Radiopharmaceuticals document (http://www.bnms.org.uk/images/stories/UKRG/UKRG_QA_Apr-12.pdf) will form part of the purchase and use strategy for Lutathera.
The BNMS has been made aware of a potential short-term difficulty in sourcing Lutetium 177 Dotatate for the treatment of neuroendocrine malignancy.