Radioligand therapy involves patients with advanced prostate cancer in Great Britain

Advanced Accelerator Applications – a Novartis company – has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Britain for Pluvicto.

The therapy – also known as lutetium vipivotide tetraxetan – treats adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.

It follows the positive scientific opinion issued in April 2022 by the MHRA for the Early Access to Medicines Scheme.

Radioligand therapy (RLT) is an emerging treatment approach that may offer an alternative treatment option for some cancer patients. RLT is administered via the bloodstream and delivers targeted radiation to cancer cells in the body, with the goal of limiting damage to surrounding tissue.

Steve Allen, acting chair of Tackle Prostate Cancer, reflected: “Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a one in two chance of surviving five years. The announcement of marketing authorisation for lutetium treatment is another positive milestone for eligible patients and their families.”

“There continues to be a real and pressing need for better treatments for people with advanced prostate cancer. This new approach is very welcome,” he added.

Alessandra Dorigo, general manager UK and Ireland, Baltics and Nordics of Advanced Accelerator Applications, concluded: “Radioligand therapy is an upcoming pillar of cancer care, and we are delighted that the UK is the second region in the world to license this pioneering treatment to advanced prostate cancer patients. We are working in partnership with the NHS to ensure system readiness so that eligible patients are able to access this innovative medicine when available.”

The MHRA has also issued a licence in Britain for gozetotide which is a radioactive diagnostic agent indicated for the identification of PSMA-positive lesions by positron emission tomography (PET) in adult patients with prostate cancer. Its licensing makes it the first diagnostic PSMA imaging tracer to receive this status in Britain.