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Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.
Chang, Elaine; Hahn, Noah M; Lerner, Seth P; Fallah, Jaleh; Agrawal, Sundeep; Kamat, Ashish M; Bhatnagar, Vishal; Svatek, Robert S; Jaigirdar, Adnan A; Bross, Peter; Shore, Neal; Kates, Max; Sachse, Karen; Brewer, Jamie R; O'Donnell, Michael A; Steinberg, Gary D; Viviano, Charles J; Bloomquist, Erik; Ribal, Maria J; Galsky, Matthew D; Oliver, Richard; Black, Peter C; Al-Ahmadie, Hikmat; Brothers, Kenneth; Pohar, Kamal; Dinney, Colin P; Feng, Zhou; Downs, Tracy M; Porten, Sima P; Smith, Angela B; Bangs, Rick; Psutka, Sarah P; Agarwal, Neeraj; Amiri-Kordestani, Laleh; Suzman, Daniel L; Pazdur, Richard; Kluetz, Paul G; Weinstock, Chana.
Afiliación
  • Chang E; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Hahn NM; Johns Hopkins Greenberg Bladder Cancer Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.
  • Lerner SP; Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
  • Fallah J; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Agrawal S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Kamat AM; Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Bhatnagar V; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA.
  • Svatek RS; Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA.
  • Jaigirdar AA; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Bross P; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Shore N; Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC, USA.
  • Kates M; Department of Urology, Johns Hopkins Greenberg Bladder Cancer Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Sachse K; Bladder Cancer Advocacy Network, Bethesda, MD, USA.
  • Brewer JR; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • O'Donnell MA; Department of Urology, University of Iowa, Iowa City, IA, USA.
  • Steinberg GD; Goldstein Bladder Cancer Program, NYU Langone Health, NYU Urology Associates, New York, NY, USA.
  • Viviano CJ; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
  • Bloomquist E; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Ribal MJ; Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.
  • Galsky MD; Hematology-Oncology, Icahn School of Medicine at Mount Sinai/Tisch Cancer Institute, New York, NY, USA.
  • Oliver R; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Black PC; Johns Hopkins Greenberg Bladder Cancer Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.
  • Al-Ahmadie H; Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.
  • Brothers K; Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Pohar K; Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD, USA.
  • Dinney CP; Department of Urology, University of Texas Health San Antonio, San Antonio, TX, USA.
  • Feng Z; Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Downs TM; Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC, USA.
  • Porten SP; Department of Urology, Johns Hopkins Greenberg Bladder Cancer Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Smith AB; Bladder Cancer Advocacy Network, Bethesda, MD, USA.
  • Bangs R; Department of Urology, University of Iowa, Iowa City, IA, USA.
  • Psutka SP; Goldstein Bladder Cancer Program, NYU Langone Health, NYU Urology Associates, New York, NY, USA.
  • Agarwal N; Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
  • Amiri-Kordestani L; Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.
  • Suzman DL; Hematology-Oncology, Icahn School of Medicine at Mount Sinai/Tisch Cancer Institute, New York, NY, USA.
  • Pazdur R; Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.
  • Kluetz PG; Department of Pathology and Laboratory Medicine, Genitourinary Pathology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Weinstock C; National Cancer Institute Bladder Cancer Task Force, Bethesda, MD, USA.
Bladder Cancer ; 9(3): 271-286, 2023.
Article en En | MEDLINE | ID: mdl-38993184
ABSTRACT

BACKGROUND:

Despite recent drug development for non-muscle invasive bladder cancer (NMIBC), few therapies have been approved by the US Food and Drug Administration (FDA), and there remains an unmet clinical need. Bacillus Calmette-Guerin (BCG) supply issues underscore the importance of developing safe and effective drugs for NMIBC.

OBJECTIVE:

On November 18-19, 2021, the FDA held a public virtual workshop to discuss NMIBC research needs and potential trial designs for future development of effective therapies.

METHODS:

Representatives from various disciplines including urologists, oncologists, pathologists, statisticians, basic and translational scientists, and the patient advocacy community participated. The workshop format included invited lectures, panel discussions, and opportunity for audience discussion and comment.

RESULTS:

In a pre-workshop survey, 92% of urologists surveyed considered the development of alternatives to BCG as a high drug development priority for BCG-naïve high-risk patients. Key topics discussed included definitions of disease states; trial design for BCG-naïve NMIBC, BCG-unresponsive carcinoma in situ, and BCG-unresponsive papillary carcinoma; strengths and limitations of single-arm trial designs; assessing patient-reported outcomes; and considerations for assessing avoidance of cystectomy as an efficacy measure.

CONCLUSIONS:

The workshop discussed several important opportunities for trial design refinement in NMIBC. FDA encourages sponsors to meet with the appropriate review division to discuss trial design proposals for NMIBC early in drug development.
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Texto completo: 1 Colección: 01-internacional Idioma: En Revista: Bladder Cancer Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Idioma: En Revista: Bladder Cancer Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos