MHRA grants marketing authorisation for Novartis’ radioligand therapy Pluvicto®▼ (lutetium (177Lu) vipivotide tetraxetan) in advanced prostate cancer in Great Britain

MHRA grants marketing authorisation for Novartis’ radioligand therapy Pluvicto^®▼ (lutetium (¹⁷⁷Lu) vipivotide tetraxetan) in advanced prostate cancer in Great Britain

 

·        Lutetium (¹⁷⁷Lu) vipivotide tetraxetan received Medicines and Healthcare Products Regulatory Agency (MHRA) authorisation for the treatment of eligible advanced prostate cancer patients in Great Britain¹, making it the first region in Europe to receive marketing authorisation. 

 

·        Locametz^®▼ (gozetotide), a PSMA-targeted positron emission tomography (PET) imaging tracer, has also received a licence from the MHRA for use in imaging prostate cancer in Great Britain²; the first diagnostic PSMA imaging tracer to receive this status from the MHRA.

 

·        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.

 

London, August 11, 2022 – 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 tissue^9,10.

 

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, Honorary Consultant Medical Oncology and Professor in Experimental Medicine, The Royal Marsden, 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.

 

 

About Pluvicto^® (lutetium (¹⁷⁷Lu) vipivotide tetraxetan)

Lutetium (¹⁷⁷Lu)  vipivotide tetraxetan, (formerly known as ¹⁷⁷Lu-PSMA-617) is indicated 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 taxanes³. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)^3-6. PSMA is a transmembrane protein that is highly expressed in the tumour of more than 80% men with prostate cancer^12-15. After administration into the bloodstream, lutetium (¹⁷⁷Lu) vipivotide tetraxetan binds with high affinity and specificity to PSMA expressing cells^16-18. Once bound, energy emissions from the radioisotope damages tumour cells, disrupting their ability to replicate and/or triggering cell death^17-19. The radiation from the radioisotope works over very short distances to limit damage to surrounding tissues^6,20-22.

 

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.  Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

 

About Locametz^® (gozetotide)

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 cancer²³. It offers imaging characteristics including accumulation in the primary tumour compared to normal tissue and shows correlation between the tumour-related tracer uptake intensity and PSA levels and Gleason scores^23,24.

 

About Advanced Accelerator Applications S.A.

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 our technology aspires to revolutionise the standard of care for a variety of tumour types. We develop radioligand theranostics 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 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 nearly 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. Find out more at https://www.novartis.com

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 

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²⁴Uprimny C, Kroiss A, Decristoforo 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.