E. David Crawford, MD; Alan H. Bryce, MD; and Bryan A. Mehlhaff, MD, presented “The Impact of a Restricted Supply of Lutetium (Pluvicto)” for the Grand Rounds in Urology audience in March 2023.
How to cite: Bryce, Alan H. Crawford, E. David. Mehlhaff, Bryan A. “The Impact of a Restricted Supply of Lutetium (Pluvicto)” March 2023. Accessed Jul 2024. https://grandroundsinurology.com/the-impact-of-a-restricted-supply-of-lutetium-pluvicto/
The Impact of a Restricted Supply of Lutetium (Pluvicto) – Summary
In a recent conversation held at the 30th Annual Perspectives in Urology: Point Counterpoint conference, March 10-12, 2023 in San Diego, California, GRU Editor-In-Chief E. David Crawford sat down with Alan H. Bryce, MD, a consultant and Chair of the Division of Hematology and Medical Oncology in the Department of Internal Medicine at Mayo Clinic in Scottsdale, Arizona; and Bryan A. Mehlhaff, MD, Medical Director of Research at the Oregon Urology Institute in Springfield, Oregon, to discuss the recent supply chain issue with lutetium Lu 177 vipivotide tetraxetan (PLUVICTO®). Dr. Crawford begins by discussing one of the most significant advances in prostate cancer – the introduction of molecular-targeted imaging as well as theranostics. He cites the drug Lutetium Lu-177 (lutetium Lu 177 vipivotide tetraxetan; trade name Pluvicto™), now U.S. Food and Drug Administration (FDA)-approved, and explains that while results have been phenomenal, supply has been a challenge with a current shortage of the drug. Dr. Crawford then introduces Drs. Bryce and Mehlhaff, and explains they have both had extensive experience with Lutetium Lu-177. Dr. Mehlhaff emphasizes that having a prostate-specific membrane antigen (PSMA) scan that will show both soft-tissue and bone disease and then a theranostic that will treat that metastasis is, in his words, “enormous.” He explains it is a game changer for some of his patients, allowing them increased quality and quantity of life, with some very challenged patients responding well. Dr. Bryce then addresses challenges, namely that supply of Lutetium Lu-177 is now restricted due to a manufacturing issue and practitioners are not currently able to refer new patients to receive this therapy. Patients already in treatment are experiencing delays—sometimes up to a month or more—but doses are getting delivered. Dr. Bryce calls this a management issue that must be addressed on a case-by-case basis, with the physician (along with the patient) making clinical decisions about whether to continue treatment or change course. He concurs with Dr. Mehlhaff, that Lutetium Lu-177 can be an effective alternative for patients whose alternatives would likely be more toxic options such as second-line chemotherapy with cabazitaxel. Dr. Bryce emphasizes the impact in terms of delay of treatment for these patients, whose overall survival is approximately 12 months. Dr. Bryce highlights the complexity of manufacturing such drugs and explains that the isotope supply is the most difficult piece of the current manufacturing challenge. Dr. Bryce expresses hope that as the U.S. manufacturing facility comes online that supply will be adequate, with Dr. Mehlhaff stating he’d like to “have it in my quiver again.”
Alan H. Bryce, MD
Alan H. Bryce, MD, is a Consultant and Chair of the Division of Hematology and Medical Oncology in the Department of Internal Medicine at Mayo Clinic in Arizona. He is the Interim Director of the Mayo Clinic Comprehensive Cancer Center in Arizona, and also serves as Chair of the Genitourinary Disease Group in the Enterprise Mayo Clinic Comprehensive Cancer Center. Dr. Bryce joined the staff of Mayo Clinic in 2011 and holds the academic rank of Associate Professor of Medicine in the Mayo Clinic College of Medicine and Science.
Bryan A. Mehlhaff, MD
A native of Oregon, Dr. Mehlhaff attended Beloit College in Wisconsin followed by medical school at Oregon Health Sciences University. After completing general surgery and urology residencies at Albany Medical Center he joined the Department of Urology as an Assistant Professor. For the past 20 years he has practiced in Eugene, Oregon. At the Oregon Urology Institute as Medical Director of Research, he oversees numerous clinical trials in advanced prostate cancer and benign prostate conditions. At Oregon Urology Institute he has developed a comprehensive bone health and advanced prostate cancer clinic. Dr. Mehlhaff is also a managing partner of Oregon Urology Institute. He is a past Board member of LUGPA and the Oregon Urology Society.
ABOUT THE AUTHOR
Researcher-physician E. David Crawford, MD, has devoted his career in medicine to educating the public about men's health issues and finding effective techniques and procedures to address prostate cancer, the most common malignancy affecting men in the United States.
He is currently a Professor of Urology and Jack A. Vickers Director of Prostate Research at the University of California, San Diego. Dr. Crawford received his medical degree from the University of Cincinnati and his postgraduate training included an internship and residency in urology at the Good Samaritan Hospital in Cincinnati. He subsequently completed a genitourinary cancer fellowship at the University of California Medical Center in Los Angeles.
Dr. Crawford is an internationally recognized expert in benign prostate hypertrophy, urologic cancers, and in particular, prostate cancer. He has conducted research in the treatment of advanced bladder cancer, metastatic adenocarcinoma of the prostate, hormone-refractory prostate cancer, and other areas of urological infections and malignancies. He has authored or coauthored over 810 scientific articles, has published seven textbooks, authored over 60 book chapters, and provided more than 2,200 educational talks for patients and physicians.
In an effort to raise public awareness about prostate health, Crawford in 1989 founded the Prostate Conditions Education Council (PCEC). The non-profit organization is comprised of a consortium of leading physicians, health educators, scientists, and men's health advocates. PCEC's advocacy for free or low-cost prostate screening has affected the lives of millions of American men. He currently chairs the PCEC.
Crawford is an active member of many national and international organizations, including the American Society of Clinical Oncology, the American Urological Association (AUA), and the American Association for the Advancement of Science. Within the AUA, he has been a member of the Committee to Study Urologic Research Funding and the prostate cancer clinical trials subcommittee. Crawford served on the board of governors, the scientific advisory board of the Southwest Oncology Group, and was chairman of the Genitourinary Cancer Committee for 27 years. This group is the largest clinical trials group in the world.
Crawford's involvement in the national prostate cancer arena has been widely recognized. He has received many honors and awards, including the CAP Cure Annual Award for Scientific Presentation in 1999 In 1997, he was presented with a 'Freddie Award" at the AMA International Health and Medical Film Competition for the program, ITV: The Cutting Edge Medical Report (Prostate Cancer: Understanding, Diagnosing, and Defeating), which Crawford hosted with special guest, retired General Norman Schwarzkopf.
Crawford again won a prestigious 'Freddie Award" 5 years ago... He is a member of Best Doctors of America and was named Healthcare Provider of the Year in the Denver Metro area by the Denver Business Journal.
He has been recognized as one of the Best Doctors of America for the past two decades and is recognized as one of the top 20 urologists in the country, for men, by Men’s Health Magazine. In 2018 he received the honor of being named the Distinguished Alumnus of the Year from the University of Cincinnati School of Medicine. In May of 2019, he received the Presidential citation from the American Urological Association recognizing for his “tireless role in genitourinary cancer research that has benefited countless urologic cancer patients.” He accepted the position of Editor in Chief of Grand Rounds in Urology in June of 2019. In 2021, he was the recipient of the Merle Stringer, M.D. annual award for excellence in medicine by the Florida State Medical Association.
