On October 27, 2021 Sesen Bio, Inc.’s (the "Company") reported that it Phase 3 VISTA trial for Vicineum arising from a 2021 FDA inspection related to the review of the Company’s Biologics License Application ("BLA") for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") (Press release, Sesen Bio, OCT 27, 2021, View Source [SID1234592027]). Sesen Bio discontinued use of the clinical site and the study investigator over four years ago when the Company learned of professional misconduct by the study investigator that was unrelated to the Phase 3 VISTA trial.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The FDA Warning Letter indicates that the study investigator did not comply with applicable statutory requirements and applicable regulations regarding conduct of clinical investigations. The study investigator operated a clinical site that was previously part of the VISTA trial, which was closed by the Company on May 26, 2017. The study investigator’s medical license was temporarily suspended on May 29, 2017 due to inaccurate recordkeeping, which was unassociated with Sesen Bio and the patients in the VISTA trial. The Company notified the FDA of the misconduct at that time.
When the clinical site was closed, five patients had completed treatment and were in post-treatment follow-up. There was no evidence found that patients were harmed by the study investigator’s actions. The Company included the corresponding patient data from the clinical site in its BLA submission to the FDA, which were thoroughly analyzed and discussed during the BLA review.
The Company did not receive any Warning Letters or Discipline Review Letters during the FDA’s review of the BLA for Vicineum from the Company’s initiation of the submission of its BLA under rolling review in December 2019 through the Company’s receipt of a Complete Response Letter from the FDA in August 2021. Sesen Bio looks forward to continuing to work collaboratively with regulators to determine the appropriate path forward for Vicineum.