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Advanced Bladder Cancer

Beyond Androgen Blockade - Exploring New Pathways for Treating mCRPC and mHSPC

APCCC 2024

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EMBARK

Recent Physician-Scientist Review Articles

  State of the Evidence Review Articles
Advanced Bladder Cancer
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PSMA-Targeted Therapy
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Transformative Evidence

  Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information

ARANOTE

Presented by Niven Mehra, MD
The 2024 ESMO annual meeting included a session on prostate cancer, featuring a discussion presentation by Dr. Niven Mehra discussing three abstracts including “Efficacy and safety of darolutamide plus ADT in patients with mHSPC from the phase 3 ARANOTE trial” by Dr. Fred Saad, “Prostate cancer efficacy results from a randomized phase 3 evaluation of transdermal estradiol versus LHRH agonists for androgen suppression in M0 prostate cancer” by Dr. Ruth Langley, and “Phenotypic and genomic characterization of de novo metastatic prostate cancer: an ancillary study of the PEACE-1 phase 3 trial” by Dr. Cedric Pobel.

ANKTIVA

  • ANKTIVA® reaches U.S. commercial and Medicare insurance coverage milestone within three months of FDA approval
  • Global expansion of commercial and clinical bladder cancer programs
    • Filing process initiated with European Medicines Agency (EMA) for regulatory approval of ANKTIVA in European Union countries
    • Global filing for BCG naïve trial initiated (QUILT-2.005) in India
  • ANKTIVA Non-Small Cell Lung Cancer (NSCLC) FDA meeting held in June 2024

Trials in Progress

  Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information

CORE-008 Trial

Presented by Trinity J. Bivalacqua, MD, PhD
 The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Trinity Bivalacqua discussing CORE-008, a phase 2, multi-arm, multi-cohort, open-label study to evaluate the safety and efficacy of cretostimogene grenadenorepvec in participants with high-risk non-muscle invasive bladder cancer (NMIBC).

CLARIFY Trial

  • Nucleus RadioPharma will manufacture the 67Cu-SAR-bisPSMA drug product at their new state-of-the-art facility in Rochester, MN.
  • The Master Services Agreement (MSA) and Clinical Supply Agreement with Nucleus RadioPharma complement the existing agreement with NorthStar Medical Radioisotopes, LLC (NorthStar) for 67Cu-SAR-bisPSMA production to expand drug manufacturing in anticipation of recruitment demand for Phase II and III trials of this product.