ML25093A078

M250408B: Slides - Green - Meeting with the Advisory Committee on the Medical Uses of Isotopes

ML25093A078
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Issue date:	04/08/2025
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M250408B
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Growth in Radiopharmaceutical Therapy Richard Green, BSPharm, RPh ACMUI Vice Chair/Nuclear Pharmacist April 9, 2025

Agenda

• History of radiopharmaceutical therapies

• Projected growth

• New radioisotopes

• Clinical trials

• New challenges 2

History of Radiopharmaceutical Therapies 3

1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 1951 I-131 NaI 1957 P-32 sodium 1974 P-32 chromic 1993 Sr-89 chloride 1997 Sm-153 Quadra-met 2002 Y-90 Zevalin 2003 I-131 Bexxar 2013 Ra-223 Xofigo 2018 Lu-177 Luta-thera 2018 I-131 Azedra 2022 Lu-177 Pluvitco Grouped into 5 Year Brackets

History of Radiopharmaceutical Therapies 4

1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 1951 I-131 NaI 1957 P-32 sodium 1974 P-32 chromic 1993 Sr-89 chloride 1997 Sm-153 Quadra-met 2002 Y-90 Zevalin 2003 I-131 Bexxar 2013 Ra-223 Xofigo 2018 Lu-177 Luta-thera 2018 I-131 Azedra 2022 Lu-177 Pluvitco 2009 2009 2021 2003 2024 2020 Grouped into 5 Year Brackets

Projected Growth Results by Year Increasing number of publications Over the last 10 years National Library of Medicine. PubMed Database Search. March 23, 2025. https://pubmed.ncbi.nlm.nih.gov/

Projected Growth Theranostics Global Market Report 2025Market Size, Trends, And Global Forecast 2025-2034. The Business Research Company. March 2025. https://www.thebusinessresearchcompany.com/report/theranostics-global-market-report

Projected Growth 7

https://www.theranostictrials.org/

• 38 companies, 45 clinical stage programs

- 8 phase III

- 28 phase I/II

New Radioisotopes 8

Copper 67 Terbium 161 Scandium 47 Rhenium 186

New Radioisotopes 9

Bismuth 213 Thorium 227 Actinium 225 Lead 212 18.7 d

New Radioisotopes https://www.theranostictrials.org/

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Therapeutic Clinical Trials

• Over 275 therapeutic clinical trials

• During 2025, data from 15 completed trials is expected to be released.

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New Challenges

• Measurement Accuracy-NIST

• Patient ready unit dose syringe pigs capable of holding 20 - 30 mL

• Proposed Revision to IAEA Safety Standard Series SSR-6 Revision 1, Regulations for the Safe Transport of Radioactive Material 2018 Edition, Table 2 A2 Values 1

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New Challenges

• Some production methods may result in undesirable radionuclidic impurities (i.e.; 177mLu,227Ac)

• Radionuclide therapy is no longer one and done, it is multi course treatment regimens, sometimes involving pretreatment with renal protectants, anti emetics, etc, and will require multidisciplinary coordination. Recommendations from subcommittee on generic checklist.

• Training & Experience - Expected growth in the number of AU application with market growth 1

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Acronyms

• ACMUI - Advisory Committee on the Medical Uses of Isotopes

• Ac225 - Actinium 225

• Bi213 - Bismuth 213

• BCMA - Barcode Medication Administration

• CAGR - Compound Annual Growth Rate

• CPOE - Computerized Prescription Order Entry 1

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Acronyms

• Cu67 - Copper 67

• eMAR - Electronic Medication Administration Record

• IAEA - International Atomic Energy Agency

• NIST - National Institute of Standards & Technology

• NRC - U.S. Nuclear Regulatory Commission

• Pb212 - Lead 212 1

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Acronyms

• PDUFA - Prescription Drug User Fee Act

• Re186 - Rhenium 186

• Sc47 - Scandium 47

• Tb161 - Terbium 161

• Th227 - Thorium 227

• IVWMS - IV Workflow Management System 1

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