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MHRA grants marketing authorisation for treatment of advanced prostate cancer

Advanced Accelerator Applications (AAA), a Novartis company, 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. 

Novartis is committed to developing prostate cancer care with targeted radioligand therapy – a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)3-6. Radioligand therapy (RLT) is an emerging treatment approach that may offer an alternative treatment option for some cancer patients8. 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. 

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. 

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. This 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.” 

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 can access this innovative medicine when available.” 


1 Pluvicto Summary of Product Characteristics. 2022.   

3 Kratochwil C, Giesel FL, Stefanova M, et al. PSMA-targeted radionuclide therapy of metastatic castration-resistant prostate cancer with 177Lu-labeled PSMA-617. J Nucl Med. 2016;57(8):1170–6. 

4 Benešová M, Schäfer M, Bauder-Wüst U, et al. Preclinical evaluation of a tailor-made DOTA-conjugated PSMA inhibitor with optimized linker moiety for imaging and endoradiotherapy of prostate cancer. J Nucl Med. 2015;56(6):914–20. 

5 Society of Nucleur Medicine and Molecular Imaging. Fact Sheet: Targeted Radionuclide Therapy and Prostate Cancer – SNMMI. Available at: https://www.snmmi.org/AboutSNMMI/Content.aspx?ItemNumber=12772 [Accessed August 2022]. 

6 Sgouros G, Bodei L, McDevitt M, et al. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nature Reviews Drug Discovery. 2020 ;19(9):589-608. 

7 Gov.Uk. Lutetium (177Lu) vipivotide tetraxetanin: Public Assessment Report (PAR) Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1066692/177Lu_vipivotide_tetraxetan_Public_Assessment_Report__PAR_.pdf [Accessed August 2022].

8 Merkel C, Whicher C, Bomanji J, et al. Realising the potential of radioligand therapy: policy solutions for the barriers to implementation across Europe. European J Nucl Med. 2020;47:1335-9. 

9 Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment. Am J Roentgenol. 2017.209(2):277-88. 

10 Kiesewetter B, Raderer M. My burning issues in neuroendocrine tumours (NET). Memo. 2018;11(4): 313-16. 

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