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MHRA approves Pluvicto® and Locametz® for prostate cancer

The UK’s regulator approved Novartis’ radioligand therapy Pluvicto®▼ and radioactive diagnostic agent Locametz® for use in advanced prostate cancer.

artist drawing of the male anatomy with the prostate highlighted

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto® (lutetium [177Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

The MHRA has also issued a licence in Great Britain for Locametz® (gozetotide) which, after radiolabelling with gallium-68, 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 Great Britain.

Radioligand therapy (RLT), which combines a targeting compound (ligand) with a therapeutic radioactive atom (radioisotope), 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.

The approval of Advanced Accelerator Applications (AAA)’s Pluvicto is based on the alternate primary endpoint results from the randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one AR pathway inhibitor and one or two taxane regimens. The study demonstrated prolonged overall survival and radiographic progression free survival with lutetium (177Lu) vipivotide tetraxetan and protocol-permitted standard of care (SOC; 551 patients) versus SOC alone (280 patients).

The incidence of adverse events, including those of grade 3 or higher, during treatment was higher in the lutetium (177Lu) vipivotide tetraxetan plus SOC group than in the SOC only group11. The most common treatment-emergent adverse events in those receiving lutetium (177Lu) vipivotide tetraxetan plus SOC (all grades) were fatigue (43.1 percent), dry mouth (38.8 percent), nausea (35.3 percent), anaemia (31.8 percent), decreased appetite (21.2 percent) and constipation (20.2 percent).

Steve Allen, Acting Chair of Tackle Prostate Cancer, commented: “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. Today’s 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.”

Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, added: “This is a major clinical advancement for people with advanced prostate cancer who have recurrent disease after androgen receptor pathway inhibitors and chemotherapy. Results from the Phase III VISION study have shown the significance of this precision medicine for patients with advanced prostate cancer and it is encouraging to see such innovations being recognised by the MHRA with this licensing authorisation.”

Following the granting of this marketing authorisation by the MHRA, Novartis, which owns AAA, will continue to work with the UK’s National Institute for Health and Care Excellence (NICE) and National Health Service (NHS) to enable eligible patients in Great Britain to access lutetium (177Lu) vipivotide tetraxetan.

Pluvicto®▼ (lutetium (177Lu) vipivotide tetraxetan) is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.

Locametz® (gozetotide) is a ready-to-use cold kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide (formally known as 68Ga-PSMA-11) solution for intravenous injection targeting prostate specific membrane antigen. It is used for PET imaging of PSMA-positive prostate cancer.