Journey of
a dose
Learn how a single dose of our cutting-edge Radioligand Therapy (RLT) is made to order and delivered with critical precision to the patient.
This site is intended for healthcare professionals outside of the United States (US) and the United Kingdom (UK).
This site is created and funded by Novartis.
01
Innovation in cancer care
RLT represents a forward leap in treating certain complex cancers, including neuroendocrine tumors and prostate cancer.1, 2, 3
A form of precision nuclear medicine, RLT recognizes and treats diseases, even when they have spread throughout the body. RLT delivers radiation to cancer cells in a targeted and precise way and limits damage to surrounding tissue.4, 5, 6, 7 This precision-medicine treatment is usually administered through an intravenous infusion.
Despite recent advances, outcomes for patients with cancer who progress after standard-of-care treatments remain poor, and new treatment options are crucial for improving long-term outcomes.8, 9, 10
With large-scale investment and significant numbers of ongoing trials, RLT has the potential to treat over 15 different types of cancer.11, 12
02
Identifying suitable patients
Radioligand Imaging (RLI) is an advanced imaging technology that enables informed treatment decisions.
Nuclear medicine has both diagnostic imaging and therapeutic components (known as theranostics). We leverage the same target molecules for both imaging and intervention: RLI identifies the cancer, and RLT damages or destroys it.3a, 13, 14, 15, 16, 17
The specialist oncologist coordinates testing and diagnosis of cancer with tests such as imaging scans, biopsy, and blood, urine, biomarker and genetic tests.18, 19
Targeted RLT requires cooperation between specialist healthcare providers and nuclear medicine. This multidisciplinary team (MDT) may include surgeons, oncologists, nuclear medicine physicians, radiologists, histopathologists, and specialist nurses.18a, 19a, 20 The MDT discusses the patient case and decides upon RLT as a potential treatment.
The oncologist coordinates with nuclear medicine to arrange a PET-CT scan, which locates cancer markers using radioactive tracers specific to the tumor type, and confirms the patient’s suitability for the intended RLT.13a, 16a, 17a, 18b
After the PET-CT scan, the MDT reviews the results to discuss the patient case, confirm treatment eligibility and plan the RLT.§
§Dependent on type and location of cancer. Sufficient uptake of RLI required to confirm patient suitability for RLT.
Once agreed, the oncologist liaises with nuclear medicine to order the appropriate RLT.
03
Placing an order
Providing made-to-order, just-in-time treatment.
Order and production of RLT take approximately 14 days.21 Once an order is placed, this sets in motion the unique manufacturing and delivery logistics required to develop and ship an RLT dose.
Our online ordering system offers a hassle-free way to schedule therapy orders. With built-in flexibility, healthcare teams can easily plan and adjust RLT orders, ensuring patients receive access to treatment when they need it.22
Customers receive an order confirmation within 24 hours †
†Depending on specific circumstances, some customers may place orders longer than two weeks prior to production. In cases when additional time is needed for approval, confirmation may not be sent within 24 hours.
04
Manufacturing RLT
Manufacturing RLT requires a deep understanding of medicine, chemistry, physics, and biology.21a Our continuous and timely supply supports the consistent delivery of beneficial therapies.
Planning an RLT dose
Novartis establishes a specialized supply chain that allows us to access the raw materials needed for production, with the manufacturing capabilities to deliver to hospitals all over the world.23
We reserve reactor capacity and finalize materials for activation in reactors, ensuring we can meet demand without delay.
Therapeutic radioisotopes are produced in special nuclear reactors or generators, then shipped to a production facility where they are bonded to the cell-targeting compound.24
We source raw materials in advance, so no time is lost
Precision and speed are essential for RLT production
Half-life dictates the timeline
Since RLT has a limited timeframe in which it can be used, each dose must reach the patient within a few days of calibration.‡21b, 25, 26
‡177Lu vipivotide tetraxetan for mCRPC has a shelf-life of 5 days and 177Lu oxodotreotide for GEP-NET has a shelf-life of 3 days.
Made-to-order treatments
Due to the limited time window for administration, RLT is produced in single-patient doses and tailored to the planned infusion date, time, and location.21c, 25a, 26a
Quality control
Production is done in a highly controlled manner and follows strict Good Manufacturing Practice (GMP) standards.21d, 24a Quality control plays a pivotal role throughout manufacturing, with dedicated professionals ensuring each batch meets the highest standards.
Following quality approval, the dose begins its journey to the patient
05
RLT delivery
Operating with a narrow time window underscores the importance of highly coordinated global logistics.
Our shipping operations occur on-demand and at scale, with extensive coordination between production sites and delivery destinations to avoid delays.
We waste no time getting the dose safely to the treatment center
06
Treating patients
Physicians treat the patients within days of dose production. The infusion is administered by trained specialists.
Appointment times take up to five hours, and the infusion is expected to take no more than 30 minutes.20a, 28 Regular appointments and tests are scheduled throughout and following the treatment cycle.
Preparing patients for RLT
Before treatment, patients are given detailed instructions to ensure they are fully prepared for the intravenous infusion of RLT.4a, 28a
The final round of quality control
Upon arrival at the treatment centre, each dose of RLT undergoes its last round of testing before administration to the patient.18c, 29, 30
Comprehensive pre-treatment testing
A series of laboratory tests are carried out to assess the health status of the patient and confirm their readiness for the treatment.4b, 28b
Medication review and adjustment
Patients may be required to temporarily stop taking specific medications to prepare for RLT.4c, 28c
Depending on patient needs, specific medicines may be given before or during RLT to enhance the therapy and manage potential side effects.28d
What happens immediately after the therapy?
Patients and healthcare providers are equipped with detailed information and guidance for aftercare and post-treatment support, which is tailored to local health and safety guidelines.4d, 28e
Radioactive material leaves the body
After the infusion, most radioactive material will naturally leave the body in the urine within a few hours or days.31, 32, 33
Safe disposal of all waste
Protocols and comprehensive guidance are in place for the safe disposal or recycling of packaging and materials.
Side effect monitoring
It is crucial to monitor patients for any side effects following RLT therapy.25b, 26e, 28f
Post-treatment stay
HCPs check radioactivity levels post-treatment. When it has dropped to a safe level, patients can leave the hospital. This could be the same day or after one to two days.§ 28g
§In some hospitals, patients may be able to go home later the same day if they are feeling well. While outpatient treatment with RLT is possible in most countries' legislation (e.g. US, Canada, UK, Spain, France), in some jurisdictions a hospitalization of several days could be required (Germany, Japan).
Discharge and recuperation
Patients are equipped with information and support for their comfort and for limiting radiation exposure to others.4e, 28h
07
Bringing RLT at scale
With RLT, the clock is not just ticking once production starts—Novartis is also racing toward a future where RLTs are delivered to more patients who need them.
Imagine the journey of one dose multiplied thousands of times, treating thousands of patients, across thousands of kilometers
This synchronized delivery is already taking place on an international scale, improving the lives of countless patients, and giving back their most precious resource: time.
Today, we are rapidly moving toward a future where RLT becomes the next essential pillar in oncology.34
We have teams across the globe dedicated to developing and manufacturing RLT for patients, and to sharing knowledge, learnings and expertise with our partners.27
Simplifying the complexities of RLT adoption at scale
We created RLTCare to make treating patients as convenient and simple a process as possible. An all-encompassing service that includes everything from comprehensive knowledge and training to site readiness support and referral coordination, RLTCare helps ensure your practice is equipped to deliver RLT with confidence and efficiency, so eligible patients can receive advanced care when they need it most.
Our all-encompassing service designed to simplify the adoption of RLT and minimize time to treatment
References
1 Strosberg J, et al. N Engl J Med. 2017;376:125–35
2 Novartis press release: NETTER-2. January 2024. Available from: https://www.novartis.com/news/media-releases/novartis-lutathera-significantly-reduced-risk-disease-progression-or-death-72-first-line-treatment-patients-advanced-gastroenteropancreatic-neuroendocrine-tumors. Last accessed: May 14, 2024.
3 Sartor O, et al. N Engl J Med. 2021;385:1091–103
4 4a 4b 4c 4d 4e Novartis. Nuclear Medicine and You. Nuclear Medicine Therapy. Available from: https://prod.dol.nuclearmedicineandyou.com/nuclear-medicine-therapy. Last accessed: May 14, 2024;
5 Novartis. Introduction to RLT and Novartis. Available from: https://www.rlthub.co.uk/introduction-to-rlt. Last accessed: June 24, 2024
6 Novartis. Research and Development – technology platforms – RLT. Available from: https://www.novartis.com/research-development/technology-platforms/radioligand-therapy. Last accessed: June 24, 2024.
7 Virgolini I, et al. Eur J Nucl Med Mol Imaging. 2018;45(3):471–95
8 Fan M, et al. BMC Cancer. 2024;24(1):67
9 Sugarawa K, et al. BMC Cancer. 2023;23(1):1051
10 Duenas JAC, et al. BMC Cancer. 2023;23(1):786
11 Novartis, Data on file. Datamonitor report. Radiopharmaceuticals: A New Approach to Cancer Treatment. March 2023. Last accessed: February 23, 2023
12 ZZimmermann R, et al. Value Initiative Newsletter 2021. Available from: https://www.oncidiumfoundation.org/wp-content/uploads/2021/07/VI-Newsletter-2021-The-rising-Role-of-Radiotheranostics-Supported-by-the-Oncidium-foundation.pdf. Last accessed: August 28, 2024.
13 13a Duan H, et al. Nanotheranostics. 2022;6:103–17
14 Weber WA, et al. J Nucl Med. 2023;64:669–70
15 The Health Policy Partnership. Radioligand therapy: Realising the potential of targeted cancer care. 2020. Available from: https://www.healthpolicypartnership.com/app/uploads/Radioligand-therapy-realising-the-potential-of-targeted-cancer-care.pdf Last accessed: May 14, 2024
16 16a Bauckneht M, et al. Diagnostics (Basel). 2020;10:598
17 17a Novartis. Nuclear Medicine and You. Nuclear Medicine Imaging. Available from: https://prod.dol.nuclearmedicineandyou.com/nuclear-medicine-imaging#work. Last accessed: May 14, 2024
18 18a 18b 18c Calais J, et al. Cancer Treat Rev. 2023:115:102524
19 19a Health Policy Partnership. Neuroendocrine cancer: an ideal patient care pathway. 2023. Available from: https://www.healthpolicypartnership.com/app/uploads/Neuroendocrine-cancer-an-ideal-patient-care-pathway.pdf. Last accessed: May 14, 2024
20 20a Ladriere T et al. Pharmaceutics. 2023; 15:1240.
21 21a 21b 21c 21d 21e 21f 21g Novartis: An Overview of Radioligand Therapies and How They Are Made. Available from: https://www.novartis.com/us-en/sites/novartis_us/files/rlt-manufacturing-factsheet.pdf. Last accessed: May 14, 2024
22 Novartis: Welcome to ROME, your unique one-stop radiopharmaceutical ordering platform to efficiently order, manage and track all of your radioligand products and needs. Available from: https://www.rltcare.novartis.com/place-order. Last accessed: May 22, 2024
23 Novartis Press Release. Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors. Apr 2024. Available from: https://www.novartis.com/news/media-releases/novartis-radioligand-therapy-lutathera-fda-approved-first-medicine-specifically-pediatric-patients-gastroenteropancreatic-neuroendocrine-tumors. Last accessed: May 14, 2024.
24 24a Dash A, et al. Nucl Med Mol Imaging. 2015;49:85–107
25 25a 25b Hennrich U and Eder M Pharmaceuticals (Basel). 2019;12:114
26 26a 26b 26c 26d 26e Hennrich U and Eder M Pharmaceuticals (Basel). 2022;15:1292
27 Novartis: Radioligand therapy: delivering now, building for the future. Available from: https://www.novartis.com/research-development/technology-platforms/radioligand-therapy/radioligand-therapy-delivering-now-building-future. Last accessed: May 22, 2024
28 28a 28b 28c 28d 28e 28f 28g 28h Cancer Research UK. Peptide receptor radionuclide therapy (PRRT). 2021. Available from: https://www.cancerresearchuk.org/about-cancer/neuroendocrine-tumours-nets/treatment/radiotherapy/peptide-receptor-radionuclide-therapy-prrt. Last accessed: May 14, 2024
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30 Advanced Accelerator Applications USA I. Lutathera prescribing information. 2023. Available from: https://www.novartis.com/us-en/sites/novartis_us/files/lutathera.pdf. Last accessed: May 14, 2024
31 Hermann K, et al. J Nucl Med. 2024;65:71–8
32 Demir M, et al. J Radiol Prot. 2016;36:269–78
33 Kurth J, et al. EJNMMI Research. 2018;8:32
34 IQVIA: Succeeding with Innovation: The State of Radioligand Therapy Readiness in Europe. Available from: https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/succeeding-with-innovation-state-of-radioligand-therapy. Last accessed: May 22, 2024
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Our dedicated RLT specialist teams aim to streamline care coordination and alleviate uncertainty, ensuring you and your patients feel confident and supported every step of the way.