The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted 177Lu-PSMA-617 Promising Innovative Medicine (PIM) designation for metastatic castration-resistant prostate cancer.
68Ga-PSMA-11, a targeted positron emission tomography (PET) imaging tracer was also given PIM designation, making it the first diagnostic imaging tracer to receive this status from the MHRA.
Prostate cancer causes over 11,500 deaths in the UK alone each year1 and men with advanced prostate cancer have high unmet need regarding quality of life and symptom control2
This recognition from the MHRA is an indication that 177Lu-PSMA-617 and 68Ga-PSMA-11 are promising candidates for the Early Access to Medicines Scheme (EAMS), aiming to provide equitable access to care for those with high unmet need.
London, UK. 23 September 2021 — Novartis today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicine (PIM) designation for 177Lu-PSMA-617, an investigational radioligand therapy (RLT) for the treatment of adult patients with prostate-specific membrane antigen (PSMA) positive metastatic prostate cancer.
The MHRA also issued PIM designation to 68Ga-PSMA-11 for the diagnosis of PSMA positive lesions by positron emission tomography (PET) in patients with prostate cancer, making it the first diagnostic imaging tracer to receive PIM designation in the UK.
PIM designation is an early indication that medicinal products, such as 177Lu-PSMA-617 and 68Ga-PSMA-11, are promising candidates for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with unmet medical need. EAMS provides an opportunity for important therapies to be used in UK clinical practice in parallel with the later stages of the regulatory process.
“Prostate cancer takes the lives of approximately 11,500 each year in the UK1 and sadly we know that men with advanced prostate cancer currently have limited treatment options,” said Alessandra Dorigo, General Manager of Advanced Accelerator Applications, UK & Ireland, Baltics and Nordics, a Novartis company. “This decision is highly encouraging for the patient community and is yet another example of the UK bringing innovative therapies to those who need them most. At AAA, a Novartis company, we understand that we must collaborate like never before to bring bold solutions to the NHS and UK patients. We look forward to working with the entire health system to provide treatments that are aligned to the priorities in the Long-Term Plan while delivering for people with cancer through targeted radioligand theragnostics, no matter where they are from or what their background.”
For the MHRA to grant a PIM designation, products must meet each of the following three criteria:
High unmet need: The conditions should be life-threatening or seriously debilitating with high unmet need, meaning there is no method of treatment, diagnosis or prevention available, or existing methods have serious limitations.
Significant advantage over current methods used: The medicinal product is likely to offer major advantage over methods currently used in the UK. Preliminary evidence should be submitted based on both non-clinical and clinical data.
Positive benefit-risk balance: The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.
Dr Gerhard Compion, Medical Lead at AAA, a Novartis company, said, “As prostate cancer is the most common cancer for males in the UK,3 and those with metastatic prostate cancer have a five-year survival rate of 30%,4 there is urgent need for new treatment and diagnostic options. This designation from the MHRA is an important milestone as it recognises the life-threatening nature and high unmet need of the advanced form of this disease. We will look to work with regulatory bodies as soon as possible to ensure as many patients can benefit from these potentially life-saving solutions.”
Plans to submit 177Lu-PSMA-617 to relevant UK regulatory bodies later this year are underway, further supporting the company’s bold ambition to reach 1 million patients by 2030.
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About 177Lu-PSMA-617 177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)5,6,7. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA8, a transmembrane protein, with high tumour-to-normal tissue uptake9,10. Once bound, emissions from the radioisotope damage tumour cells, disrupting their ability to replicate and/or triggering cell death11,12,13. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells.9,10,13
About 68Ga-PSMA-11 68Ga-PSMA-11 is a radiotracer targeting prostate specific membrane antigen. It is used for PET imaging of PSMA positive prostate cancer.14 It offers attractive imaging characteristics including favourable tumour-to-background ratio and shows correlation between the tumour-related tracer uptake intensity and PSA levels and Gleason scores.14,15
About Advanced Accelerator Applications Advanced Accelerator Applications, a Novartis company, is reimagining nuclear medicine and cancer care to improve and extend people’s lives. As one of Novartis’ oncology platforms, under the Bold4Cure strategy, our technology aspires to revolutionise the standard of care for a variety of tumour types. We develop radioligand theragnostics and our bold ambition is to reach 1 million patients by 2030, delivering solutions for the patients of tomorrow with what we believe may become the future standard of care in oncology areas with the highest unmet medical needs. Find out more at www.adacap.com.
About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative 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 nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
In 2018, Novartis supported a total of 17,458 UK jobs, of which it directly employed 1,268 full time equivalent workers 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 the single largest industry sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.
 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.
 Eder M, Schäfer M, Bauder-Wüst U, et al. 68Ga-complex lipophilicity and the targeting property of a urea-based PSMA inhibitor for PET imaging. Bioconjug Chem 2012; 23(4):688–97.
 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.
 Haberkorn U, Eder M, Kopka K, et al. New Strategies in Prostate Cancer: Prostate-Specific Membrane Antigen (PSMA) Ligands for Diagnosis and Therapy. Clin Cancer Res. 2016; 22(1):9-15.
 Violet J, Jackson P, Ferdinandus J et al. Dosimetry of (177)Lu-PSMA-617 in metastatic castration-resistant prostate cancer: correlations between pretherapeutic imaging and whole-body tumor dosimetry with treatment outcomes. J Nucl Med. 2019; 60(4):517–23.
 Current K, Meyer C, Magyar CE et al. Investigating PSMA-targeted radioligand therapy efficacy as a function of cellular PSMA levels and intra-tumoral PSMA heterogeneity. Clin Cancer Res 2020; 26(12):2946–55.
 Kassis A. Therapeutic Radionuclides: Biophysical and Radiobiologic Principles. Semin Nucl Med. 2008; 38(5): 358–366.
 Fendler W, Stuparu A, et al. Establishing 177Lu-PSMA-617 Radioligand Therapy in a Syngeneic Model of Murine Prostate Cancer. J Nucl Med 2017; 58: 1786–1792.
 Ruigrok E, van Vliet N, et al. Extensive preclinical evaluation of lutetium-177-labeled PSMA-specific tracers for prostate cancer radionuclide therapy. Eur J Nucl Med Mol Imaging. 2020; 48, 1339-1350.
 Eiber, M. et al. Evaluation of Hybrid 68Ga-PSMA Ligand PET/CT in 248 Patients with Biochemical Recurrence After Radical Prostatectomy. J. Nucl. Med. 2015; 56, 668–74.
 Uprimny, C. et al. 68Ga-PSMA-11 PET/CT in primary staging of prostate cancer: PSA and Gleason score predict the intensity of tracer accumulation in the primary tumour. Eur. J. Nucl. Med. Mol. Imaging. Springer Berl. Heidelb 2017; 44, 941–9.