" class="no-js "lang="en-US"> MHRA Grants Marketing Authorisation for Novartis’ Radioligand Therapy Pluvicto®▼ (Lutetium (¹⁷⁷lu) Vipivotide Tetraxetan) in Advanced Prostate Cancer in Great Britain - Medtech Alert
Friday, May 24, 2024

MHRA Grants Marketing Authorisation for Novartis’ Radioligand Therapy Pluvicto®▼ (Lutetium (¹⁷⁷lu) Vipivotide Tetraxetan) in Advanced Prostate Cancer in Great Britain

Advanced Accelerator Applications (AAA), a Novartis company,  today announced that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation in Great Britain for 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 taxanes1.

This follows the positive scientific opinion issued for lutetium (177Lu) vipivotide tetraxetan in April 2022 by the MHRA for the Early Access to Medicines Scheme (EAMS)7.

The MHRA has also issued a licence in Great Britain for 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 cancer2. Its licensing makes it the first diagnostic PSMA imaging tracer to receive this status in
Great Britain.

Radioligand therapy (RLT) is an emerging treatment approach that may offer an alternative treatment option for some cancer patients8. It combines a targeting compound (ligand) with a therapeutic radioactive atom (radioisotope)3-6. RLT is administered via the bloodstream and delivers targeted radiation to cancer cells in the body, with the goal of limiting damage to surrounding tissue9,10.

Steve Allen, Acting Chair of Tackle Prostate Cancer, said, “Far too many people are still dying each year from prostate cancer. Tragically, those diagnosed with metastatic prostate cancer will only have about a 1 in 2 chance of surviving 5 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.”

MHRA marketing authorisation of lutetium (177Lu) vipivotide tetraxetan is based on the alternate primary endpoint results from the Novartis randomised, open-label, international, multi-centre, Phase III VISION trial, where patients with progressive PSMA positive mCRPC treated with at least one androgen-receptor–pathway inhibitor and one or two taxane regimens11. 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) vs. SOC alone (280 patients)11. 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%), dry mouth (38.8%), nausea (35.3%), anaemia (31.8%), decreased appetite (21.2%) and constipation (20.2%)11.

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, said, “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.”

Alessandra Dorigo, General Manager UK & Ireland, Baltics and Nordics of Advanced Accelerator Applications, a Novartis company, said, “Our mission is to improve and extend the lives of people living with cancer and treatments like our innovative targeted radioligand therapy, lutetium (177Lu) vipivotide tetraxetan, are vital in achieving this. 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.”

Following the granting of this marketing authorisation by the MHRA, Novartis will continue to work with NICE and NHS stakeholders to enable eligible patients in Great Britain to access lutetium (177Lu) vipivotide tetraxetan.

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