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Bladder Cancer: Update Bulletin #3 [May 2018]

Product Code:
Publication Date:
May 2018

This edition presents key opinion leader (KOL) views on recent developments in the Bladder Cancer market. Topics covered include: the approval of a four-weekly dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab) in the US; the initiation of a Phase III study for Astellas and Seattle Genetics’ anti-Nectin-4 antibody drug conjugate (ADC) enfortumab vedotin (ASG-22ME); the planning of a Phase II/III study for Bayer’s, pan-fibroblast growth factor receptor (FGFR) 1-4 inhibitor rogaratinib (BAY1163877).

Business Questions:

  • Is the newly-approved, four-weekly dosing schedule for Opdivo likely to provide any benefits in terms of the treatment of bladder cancer?
  • Is Opdivo’s new dosing schedule likely to affect the extent to which it is prescribed for patients with bladder cancer and, if so, how will this impact other checkpoint inhibitors, e.g. Keytruda and Tecentriq, used in this setting?
  • Can the anti-Nectin-4 activity demonstrated by enfortumab vedotin in preclinical studies be viewed as a reliable indicator of the drug’s potential efficacy in a clinical setting?
  • How do KOLs view the recently initiated Phase III study investigating enfortumab vedotin? Do they think it will generate positive results?
  • How readily will physicians prescribe enfortumab vedotin if it demonstrates a survival benefit for patients with bladder cancer?
  • Do KOLs think that FGFR inhibition will prove to be a safe and effective approach for treating bladder cancer?
  • How important is the choice of biomarker for identifying patients who will receive the most benefit from treatment with rogaratinib?
  • How do KOLs compare and contrast Bayer’s rogaratinib with Janssen’s pan-FGFR inhibitor erdafitinib (JNJ42756493)?
  • If the outcome of rogaratinib’s upcoming Phase II/III trial is positive, will this be sufficient to guarantee the drug’s success within the bladder cancer market?


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