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Novartis announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting. With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions, as determined by the FDA.1
BACKGROUND
Metastatic castration-resistant prostate cancer remains fatal despite recent advances. Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer. Lutetium-177 (177Lu)–PSMA-617 is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the surrounding microenvironment.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Scott T. Tagawa, MD
At the 2022 ASCO Annual Meeting, the poster session focused on Prostate, Testicular, and Penile cancers on Monday afternoon included a presentation from Dr. Scott T. Tagawa discussing the tolerability of theranostic treatment with 177Lu-PSMA among men with metastatic castration-resistant prostate cancer (mCRPC), stratified by their treatment exposure, in men treated within the VISION trial.
Presented by Masatoshi Hotta, MD, PhD
At the 2022 ASCO Annual Meeting, the poster session focused on Prostate, Testicular, and Penile cancers and included a presentation from Dr. Masatoshi Hotta discussing outcomes of theranostic treatment with 177Lu-PSMA, among patients who would be deemed ineligible for therapy according to criteria used for inclusion in the VISION trial.
Presented by Nitin Vaishampayan, MD, BA
At the 2022 ASCO Annual Meeting, the oral abstract session focused on Prostate, Testicular, and Penile cancers on Sunday morning included a presentation from Dr. Nitin Vaishampayan discussing subgroup analyses of the VISION trial examining 177Lu-PSMA-617 in men with heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC).
Presented by Andrew J. Armstrong, MD, MSc
At the 2022 ASCO Annual Meeting,  the oral abstract session focused on Prostate, Testicular, and Penile cancers on Sunday morning included a presentation from Dr. Andrew J. Armstrong discussing the prognostic value of baseline [68Ga]Ga-PSMA-11 PET imaging in men undergoing theranostic treatment with 177Lu-PSMA-617 for heavily pre-treated metastatic castration-resistant prostate cancer (mCRPC) in the VISION trial.
Presented by Matthew Smith, MD, PhD
In the session of the 2022 Advanced Prostate Cancer Consensus Conference focusing on the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), Dr. Matthew Smith discussed the role of prostate specific membrane antigen (PSMA)-lutetium radionuclide therapy, including considerations regarding monotherapy, combination therapy, and patient selection.
Presented by Ajeet Gajra FACP, MD
Dr. Garja presented a poster focused on understanding how community-based medical oncologists plan to integrate 177Lu-PSMA-617 into patient management. How 177Lu-PSMA-617 approval will affect the treatment landscape of mCRPC depends on how community-based medical oncologists uptake this new treatment approach.
Presented by Ken Herrmann, MD, MBA
During the 2022 GU ASCO Cancer Symposium, Dr. Herrmann presented a poster assessing [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) dosimetry among patients treated on the phase 3 VISION trial (NCT03511664).
Presented by Michael J. Morris, MD
(UroToday.com) The Society of Urologic Oncology (SUO) annual winter meeting included an advanced prostate cancer session and a presentation by Dr. Michael Morris discussing the VISION trial and integration of PSMA-targeted therapy for advanced prostate cancer.
Presented by Ana Kiess, MD, PhD
The 2021 ASTRO Annual Meeting included a joint ASTRO/SNMMI session on prostate cancer molecular imaging and radiotheranostics and a presentation by Dr. Ana Kiess discussing the current and future management paradigms for metastatic castration-resistant prostate cancer (mCRPC).
Presented by Eleni Efstathiou, MD

The APCCC 2021 meeting session discussing PSMA in diagnostics and therapy included a presentation by Dr. Eleni Efstathiou discussing the contagious enthusiasm of PSMA-driven therapeutics. 

 

Presented by Charles Ryan, MD
The Advanced Prostate Cancer Consensus Conference 2021 virtual meeting session discussing PSMA in diagnostics and therapy included a presentation by Dr. Charles Ryan discussing the best use of Lutetium-PSMA and where to place it when sequencing therapies, including treatment monitoring.
Presented by Karim Fizazi, MD, PhD
 The ESMO 2021 annual meeting’s prostate cancer mini oral session included a presentation by Dr. Karim Fizazi discussing health-related quality of life, pain, and safety outcomes in the phase 3 VISION study. [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) delivers β-particle radiation to prostate-specific membrane antigen (PSMA) expressing cells and the surrounding microenvironment.
Presented by Silke Gillessen, MD
Silke Gillessen discussed the recently published TheraP1 and VISION2 trials. Dr. Gillessen notes that in the metastatic castration-resistant prostate cancer (mCRPC) setting, we now have several treatment options that offer a survival benefit, including abiraterone, cabazitaxel, docetaxel, enzalutamide, radium-223, sipuleucel-T, olaparib, and now 177Lu-PSMA-617.
Presented by Karim Fizazi, MD, Ph.D
Dr. Karim Fizazi finished off the thematic session of Treatment Sequencing in Metastatic Prostate Cancer with a presentation on the role of PSMA in diagnostics and treatment of metastatic prostate cancer.
Presented by Gero Kramer, MD
(UroToday.com)  Dr. Gero Kramer reviews the systemic treatment options for metastatic castration-resistant prostate cancer (mCRPC) and highlights some recent developments.
Presented by Johann De Bono, MD, MSc, Ph.D., FRCP, FMedSci
The EAU 2021 Annual Meeting included a presentation by Johann De Bono discussing the VISION trial, a phase 3 study of 177Lu-PSMA-617 in patients with mCRPC. As PSMA is highly expressed in prostate cancer and mCRPC lesions, the combination of PSMA-617 with the beta-emitter lutetium allows for the targeted delivery of ß-particle radiation to PSMA-expressing cells and the surrounding microenvironment.
Presented by Michael Morris, MD
(UroToday.com) There has been a dramatic and rapid proliferation of systemic therapy options in advanced prostate cancer since the introduction of docetaxel for metastatic castration resistant prostate cancer (mCRPC) in 2004. These newer treatments have included a number of novel hormonal therapies (including abiraterone acetate and enzalutamide),
Presented by Mary-Ellen Taplin, MD
(UroToday.com)  Dr. Taplin began her discussion of the VISION trial by first reviewing the current therapeutic landscape of prostate cancer. While there are many life-prolonging options, unfortunately, the duration of response to these therapies in sequence is often short. The VISION trial was set up to evaluate the use of lutetium-PSMA in late-stage advanced prostate cancer
Presented by Michael J. Morris, MD
(UroToday.com) In this presentation, Dr. Michael Morris presented the results of the phase 3 VISION trial evaluating the radiopharmaceutical lutetium-PSMA (Lu-PSMA) in patients with metastatic castration-resistant prostate cancer.
Presented by Mary-Ellen Taplin, MD
Following Micheal Morris’s presentation of the results of the phase III VISION trial of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer in the Plenary Session of the 2021 ASCO, Dr. Mary-Ellen Taplin from the Dana Farber Cancer Institute provided a discussant overview of these data and helped to contextualize how we may apply them to our practices.
Presented by Micheal Morris, MD
In a plenary presentation at the 2021 ASCO Annual Meeting, Dr. Morris presented the first results of the VISION trial, a phase III study assessing lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer.
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