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Flexible Scope Indication Approved for Bladder Imaging Agent

Ariela Katz
Published: Monday, Feb 26, 2018

Ashish Kamat, MD

Ashish Kamat, MD
The FDA recently approved a supplemental new drug application (sNDA) for Blue Light Cystoscopy (BLC) with Cysview for surveillance of bladder cancer, according to Photocure, the manufacturer of Cysview.1

Using a flexible scope in the outpatient setting could also reduce the costs of treating and monitoring patients with bladder cancer by treating some smaller lesions in the office. “In patients who present with bladder cancer, one of the biggest problems we have in the United States and globally is that it is one of the biggest health expenditures, both for the patient and for the clinician. It is the most expensive cancer to diagnose and treat, mainly because patients who are fortunate enough to save their bladders have recurrences of tumors, so they have to go through multiple procedures and treatments,” Kamat said.

References

  1. Photocure announces U.S. FDA approval of new indication for blue light cystoscopy with Cysview [press release]. Oslo, Norway: Photocure Inc; February 16, 2018. https://globenewswire.com/news-release/2018/02/16/1357299/0/en/Photocure-Announces-U-S-FDA-Approval-of-New-Indications-for-Blue-Light-Cystoscopy-with-Cysview.html. Accessed February 26, 2018.
  2. Cysview (hexaminolevulinate hydrochloride) [prescribing information]. Oslo, Norway: Photocure Inc; 2010. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022555s000lbl.pdf. Accessed January 5, 2018.
  3. Jocham D, Witjes F, Wagner S, et al. Improved detection and treatment of bladder cancer using hexaminolevulinate imaging: a prospective, phase III multicenter study. J Urol. 2005;174(3):862-866. doi: 10.1097/01.ju.0000169257.19841.2a.
  4. Positive data from phase 3 US blue light cystoscopy with Cysview study presented at AUA 2017 meeting in Boston [press release]. Princeton, NJ: Photocure Inc; May 14, 2017. https://www.prnewswire.com/news-releases/positive-data-from-phase-3-us-blue-light-cystoscopy-with-cysview-study-presented-at-aua-2017-meeting-in-boston-300457204.html. Accessed January 5, 2018.

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