Early access issued for eligible patients in the UK for radioligand therapy in advanced prostate cancer

Early access issued for eligible patients in the UK for radioligand therapy in advanced prostate cancer 

• 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 cancer¹. 

• Prostate cancer causes over 11,500 deaths in the UK alone each year, with a further 52,300 cases diagnosed annually². The outlook for patients diagnosed with advanced prostate cancer is poor³ with only a 49% 5 year survival rate³.

 London, UK, 6 April 2022 – Advanced Accelerator Applications (AAA), a Novartis company, today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued lutetium (¹⁷⁷Lu) vipivotide tetraxetan (formerly known as ¹⁷⁷Lu-PSMA-617), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS) 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. Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is an investigational radioligand therapy (RLT).

The EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need and no access to other alternative treatments⁴. This positive scientific opinion enables eligible patients in the UK early pre-license access to lutetium (¹⁷⁷Lu) vipivotide tetraxetan while the MHRA completes its full marketing authorisation application (MAA) review expected later this year.

Alessandra Dorigo, General Manager of Advanced Accelerator Applications, UK & Ireland, Baltics and Nordics, a Novartis company, 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 alone², 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.”

For the MHRA to provide a positive scientific opinion through EAMS, the medicine must first have received a promising innovative medicine (PIM) designation. Novartis received PIM designation for lutetium (¹⁷⁷Lu) vipivotide tetraxetan in September 2021⁵.

The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine. The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its license⁴.

Dr Gerhard Compion, Medical Lead at AAA, a Novartis company, said, “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.”

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About lutetium (¹⁷⁷Lu)  vipivotide tetraxetan

Lutetium (¹⁷⁷Lu) vipivotide tetraxetan is an investigational PSMA-targeted radioligand therapy for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle) ^7-10. Prostate Specific Membrane Antigen (PSMA) is a transmembrane protein that is highly expressed in the tumour of more than 80% men with prostate cancer^11-14. After administration into the bloodstream, lutetium (¹⁷⁷Lu) vipivotide tetraxetan binds with high affinity and specificity to PSMA expressing cells^15-17. Once bound, radiation from lutetium (¹⁷⁷Lu) damages tumour cells, disrupting their ability to replicate and/or triggering cell death^16-18. The radiation from the radioisotope works over very short distances to limit damage to surrounding tissues^10,19-21.

About Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.

In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials, in the UK. For more information, please visit www.novartis.co.uk.

Novartis UK is on Twitter. Sign up to follow @NovartisUK at www.twitter.com/novartisuk

About Advanced Accelerator Applications S.A.

Advanced Accelerator Applications, S.A. (AAA), a Novartis company, is developing targeted radioligand therapies and precision imaging radioligands for oncology indications. We are committed to transforming patients’ lives by leading innovation in nuclear medicine. AAA has a legacy as a leader in radiopharmaceutical drugs for Positron Emission tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging.

References

[1]GOV.UK. Lutetium (177Lu) vipivotide tetraxetanin: Public Assessment Report (PAR) Available online: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1066692/177Lu_vipivotide_tetraxetan_Public_Assessment_Report__PAR_.pdf [Accessed April 2022]

2Data were provided by the National Cancer Registration and Analysis Service (part of Public Health England), on request through the Office for Data Release, July 2021

3NICE. NICE impact prostate cancer. (2020). Available at: https://www.nice.org.uk/Media/Default/About/what-we-do/Into-practice/measuring-uptake/prostate-cancer/nice-impact-prostate-cancer.pdf [Last accessed: March 2022]

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7Kratochwil 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):1170–6.8

⁸Benešová 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.

⁹ Society of Nucleur Medicine and Molecular Imaging. 2022. Fact Sheet: Targeted Radionuclide Therapy and Prostate Cancer - SNMMI. [online] Available at: <https://www.snmmi.org/AboutSNMMI/Content.aspx?ItemNumber=12772> [Accessed March 2022].

¹⁰Sgouros, G., Bodei, L., McDevitt, M. and Nedrow, J., 2020. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nature Reviews Drug Discovery, 19(9), pp.589-608.

¹¹Bostwick, D.G., Pacelli, A., Blute, M., Roche, P. and Murphy, G.P., 1998. Prostate specific membrane antigen expression in prostatic intraepithelial neoplasia and adenocarcinoma: a study of 184 cases. Cancer: Interdisciplinary International Journal of the American Cancer Society, 82(11), pp.2256-226.

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¹³Pomykala, K.L., Czernin, J., Grogan, T.R., Armstrong, W.R., Williams, J. and Calais, J., 2019. Total-body 68Ga-PSMA-11 PET/CT for bone metastasis detection in prostate cancer patients: potential impact on bone scan guidelines. Journal of Nuclear Medicine, 61(3), pp.405-411.

¹⁴Hupe, M.C., Philippi, C., Roth, D., Kümpers, C., Ribbat-Idel, J., Becker, F., Joerg, V., Duensing, S., Lubczyk, V.H., Kirfel, J. and Sailer, V., 2018. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Frontiers in oncology, 8, p.623.

¹⁵Liu, H., Rajasekaran, A.K., Moy, P., Xia, Y., Kim, S., Navarro, V., Rahmati, R. and Bander, N.H., 1998. Constitutive and antibody-induced internalization of prostate-specific membrane antigen. Cancer research, 58(18), pp.4055-4060.

¹⁸Kassis A. Therapeutic Radionuclides: Biophysical and Radiobiologic Principles. Semin Nucl Med. 2008; 38(5): 358–366.

¹⁹Pouget, J., Lozza, C., Deshayes, E., et al., 2015. Introduction to Radiobiology of Targeted Radionuclide Therapy. Frontiers in Medicine, 2.

²⁰Yordanova, A., Eppard, E., Kürpig, et al., 2017. Theranostics in nuclear medicine practice. OncoTargets and Therapy, Volume 10, pp.4821-4828.

²¹European Medicines Agency. 2022. EndolucinBeta - European Medicines Agency. [online] Available at: <https://www.ema.europa.eu/en/medicines/human/EPAR/endolucinbeta> [Accessed March 2022].

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