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CYSVIEW® Supplemental New Drug Application (SNDA) in Priority Review by FDA

On Wednesday, October 18, the US Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) for Cysview® on a priority review basis, which  a decision is expected in the first half of 2018.  Photocure is looking to expand Cysview’s label to include its use in the outpatient setting to detect the recurrence of bladder cancer using a flexible cystoscope, the detection of carcinoma in situ (CIS) and the repeat administration of Cysview.


“We are delighted to see the FDA expedite the review for this sNDA as it will offer patients improved surveillance of their Non-Muscle Invasive Bladder Cancer (NMIBC).”

Andrea Maddox Smith, BCAN CEO