Oncology Insights: March 2025 - Prime Therapeutics
Radiopharmaceutical discovery and use is gaining momentum
Author: Abby Kim, PharmD, BCOP
Introducing Abby Kim, PharmD, BCOP
Abby Kim, a Board-Certified Oncology Pharmacist (BCOP), is a key member of Prime Therapeutics' Specialty Clinical Strategy and Innovation team. With a robust background in clinical practice and leadership at academic medical centers, Abby has worked extensively with both pediatric and adult oncology patients. Her dedication to oncology thought leadership and her drive for innovation and excellence are evident in her work.
In this edition of Oncology Insights, Abby explores radiopharmaceuticals.
The use of internal radiation therapy via administration of radiopharmaceuticals is beginning to disrupt the oncology armamentarium as discovery and use is gaining momentum.¹˒²˒³
Radiopharmaceuticals are drugs containing a radioactive isotope, which is an element that emits radiation during its decay. They are categorized as diagnostic, therapeutic or both.³˒⁴ Diagnostic radiopharmaceuticals have historically been more prevalent and widely used for cancer detection, staging and monitoring. However, the use of therapeutic radiopharmaceuticals is growing due to interest in their targeted mechanism of delivery, advances in technology resulting in more effective and safer agents and clinical success.³ Some radiopharmaceuticals are designed similar to antibody drug conjugates such as fam-trastuzumab deruxtecan (Enhertu) and sacituzumab govitecan (Trodelvy), in that they also contain a linker and targeting molecule to help take the radioactive isotope directly to the cancer cells.⁵
In 1951, the approval of sodium iodide I-131 marked the beginning of the successful use of therapeutic radiopharmaceuticals for diagnosis and treatment of thyroid cancer. It took another 50 years to see additional approvals that have been met with variable success due to efficacy as well as competition from other drugs entering the market at the same time.² Lutetium Lu 177 dotatate (Lutathera) was approved in 2018 for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) demonstrating improved progression free survival when combined with octreotide vs. octreotide alone (22.8 months vs. 8.5 months), marking a significant advancement in the treatment of this uncommon and difficult to treat tumor.⁶ Pluvicto + best standard of care (BSOC), approved in 2022 for PSMA-positive metastatic castration-resistant prostate cancer, also demonstrated statistically significant improvements in median overall survival (15.3 months vs. 11.3 months) and radiographic progression free survival (8.7 months vs. 3.4 months) when compared to BSOC.⁷
The success of these agents has garnered interest in continued research and development. It is believed that any tumor with a targetable molecule on the surface of its cells and a blood supply sufficient to deliver drugs could potentially be treated with a radiopharmaceutical.¹˒⁵ With a number of agents in clinical use, many in late-phase clinical trials and research in a range of cancers such as melanoma, lung cancer, colorectal cancer and leukemia some key opinion leaders believe that we may have a full cabinet of radiopharmaceutical options in the coming years.²˒⁸
FDA-approved radiopharmaceuticals⁴
Initial approval | Name | Indication | Wholesale acquisition cost (WAC) |
---|---|---|---|
1951 | Sodium iodide I-131 | Thyroid carcinoma | Not available |
1997 | Samarium Sm 153 lexidronam (Quadramet)* | Osteoblastic metastatic bone lesion pain | Discontinued |
2002 | Yttrium-90 glass microspheres (Therasphere) Yttrium-90 resin microspheres(SIR-Spheres) |
Unresectable hepatocellular carcinoma (HCC) Metastatic liver tumors |
Not available |
2003 | Ibritumomab tiuxetan (Zevalin) | Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma Previously untreated follicular non-Hodgkin’s lymphoma after achieving a partial or complete response to first-line chemotherapy |
$66,805 |
2003 | Iodine-131 tositumomab (Bexxar)* | Relapsed or refractory, low-grade, follicular or transformed non-Hodgkin’s lymphoma | Discontinued |
2013 | Radium Ra 223 dichloride (Xofigo) | Prostate cancer, castration resistant with symptomatic bone metastases and no known visceral metastatic disease | $180,513 |
2018 | Lutetium Lu 177 dotatate (Lutathera) | Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors | $239,235 |
2022 | Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) | PSMA-positive metastatic castration-resistant prostate cancer | $292,222 |
The radiopharmaceutical market has seen changes over the years in addition to the approval of new agents. In 2023, the Food and Drug Administration reclassified radiopharmaceuticals from devices to drugs paving the way for Pharmacy and Therapeutics committee oversight and enabling 340B procurement.⁴ In 2025 the Center for Medicare and Medicaid Services (CMS) made changes to the reimbursement structure for diagnostic radiopharmaceuticals which had historically been bundled into the cost of the imaging test. CMS now reimburses diagnostic radiopharmaceuticals separately when they exceed a per-day cost of $630 in the hospital outpatient setting potentially increasing use and equitable access.⁹ With a changing diagnostic reimbursement structure as well as wholesale acquisition costs of currently approved therapeutic agents nearing $300,000 per therapy course, spend on radiopharmaceuticals is expected to rise.⁹˒¹⁰˒¹¹
Innovative approaches in oncology are continuously reshaping the landscape of cancer therapy. With radiopharmaceutical innovation accelerating, these treatments are set to play an increasingly vital role in the fight against cancer offering new treatment options to patients.
All brand names are property of their respective owners.
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National Cancer Institute. (2020, October 26). Radiopharmaceuticals: radiation therapy enters the molecular age. https://www.cancer.gov/news-events/cancer-currents-blog/2020/radiopharmaceuticals-cancer-radiation-therapy. Accessed February 20, 2025.
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Salerno K, Roy S, Ribaudo C, et al. A primer on radiopharmaceutical therapy. Int J Radiat Oncol Biol Phys. 2023;115(1):48-59.
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Buatti J, Pryma D, Kiess A, et al. A framework for patient-centered pathways of care for radiopharmaceutical therapy: an ASTRO consensus document. Int J Radiat Oncol Biol Phys. 2021;109(4):913-922.
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IPD Analytics. (2025, February). Radiopharmaceuticals primer. Accessed February 20, 2025.
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Galindo, A. (2024, February 2). What are radiopharmaceuticals?. International Atomic Energy Agency. https://www.iaea.org/newscenter/news/what-are-radiopharmaceuticals. Accessed February 20, 2025.
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Lutathera® [package insert]. Millburn, NJ; Novartis; October 2024.
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Pluvicto [package insert]. Millburn, NJ; Novartis; October 2022.
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Oh W, Nauseef J. (2025, February 5-7). Radiopharmaceuticals for cancer therapy. [Conference presentation]. Precision Medicine World Conference 2025, Santa Clara, CA, United States.
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Society of Nuclear Medicine and Molecular Imaging. (2024, November 1). In major win for patients, CMS adjusts nuclear medicine reimbursement policy, expanding access to life-saving scans. https://snmmi.org/Web/Web/News/Articles/CMS-Adjusts-Nuclear-Medicine-Reimbursement-Policy--Expanding-Access-to-Life-Saving-Scans.aspx. Accessed February 20, 2025.
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Biospace. (2023, December 5). Updated: radiopharmaceuticals market predicted to grow rapidly over next decade. https://www.biospace.com/radiopharmaceuticals-market-predicted-to-grow-rapidly-over-next-decade. Accessed February 20, 2025.
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Biospace. (2022, February 22). Oncology radiopharmaceuticals market key trends and expansion opportunities. https://www.biospace.com/oncology-radiopharmaceuticals-market-key-trends-and-expansion-opportunities-2021-2031. Accessed February 20, 2025.