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Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guerin (BCG)

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Trial Profile

Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guerin (BCG)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Nov 2022

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At a glance

  • Drugs Oportuzumab monatox (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Therapeutic Use
  • Sponsors Sesen Bio; Viventia Biotechnologies

    • Most Recent Events

    • 09 Dec 2021 According to a Sesen Bio media release, company encouraged to submit the final VISTA trial results with the resubmission; and Anticipated randomized trial design is aligned with guidance the Company has received from the European Medicines Agency, which may help to coordinate the regulatory paths forward for Vicineum in the US and the European Union.
    • 09 Dec 2021 According to a Sesen Bio media release, company anticipated regulatory path forward for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting). Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial.
    • 10 Aug 2020 According to a Sesen Bio media release, the company anticipates to complete BLA submission in the fourth quarter of 2020 with potential approval in mid-2021.

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