Advanced Accelerator Applications (AAA), a Novartis company, has announced that eligible patients in the UK have been granted early access for radioligand therapy in advanced prostate cancer, a disease which causes over 11,500 deaths in the UK alone each year.
A positive scientific opinion has been issued for lutetium (177Lu) vipivotide tetraxetan, for the Early Access to Medicines Scheme (EAMS) by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in eligible patients with advanced prostate cancer.
Dr Gerhard Compion, medical lead at AAA, commented: “The positive scientific opinion for an Early Access to Medicines Scheme for lutetium (177Lu) vipivotide tetraxetan in this group of patients with a life-threatening disease shows the clear unmet medical need recognised by the MHRA.
“Patients who have metastatic prostate cancer classified as CRPC may have already had many lines of treatment before, including chemotherapy and hormone therapy. Their life expectancy is limited and they may have run out of other treatment options. I am very relieved that eligible patients will now be able to access this radioligand therapy in England while the MHRA completes the Marketing Authorisation Application review.”
The EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines which have not yet received a marketing authorisation, when there is a clear unmet need and no access to other alternative treatments.
For the MHRA to provide a positive scientific opinion through the scheme, the medicine must first have received a promising innovative medicine (PIM) designation. Novartis received PIM designation for lutetium (177Lu) vipivotide tetraxetan in September 2021.
Alessandra Dorigo, general manager of AAA, UK and Ireland, Baltics and Nordics, said: “We at AAA see the EAMS decision for lutetium (177Lu) vipivotide tetraxetan as a real opportunity for those eligible advanced prostate cancer patients in need of treatment in England.
“With over 11,500 prostate cancer deaths every year in the UK alone, and few alternative treatments, there is an urgent need to make new and improved treatments available. We are committed to continuing our work in collaboration with the NHS to improve access to innovative treatments.”