Case Study: Global Biotechnology Company achieves accelerated FDA approval for novel bladder cancer treatment with Perceptive

Supporting Accelerated Approval of Novel Bladder Cancer Treatment Perceptive Imaging provides focused support to drive successful FDA submission

Global Biotechnology Company engaged Perceptive to support its Phase 2 bladder cancer trial, which enrolled over 400 patients across more than 100 sites in North America and Europe. The sponsor faced high discordance between site and central readers in RECIST-based assessments of baseline measurable disease for an ORR primary endpoint—an issue common in bladder cancer that threatened the integrity of the efficacy data. Perceptive provided imaging services including an imaging charter, site training, and a centralized review network of five radiologists.

Perceptive addressed the problem with targeted, case‑based training for sites and central readers, ongoing medical-lead discussions with the sponsor, and harmonized assessment guidance that narrowed discordance across readers. As a result of Perceptive’s medical imaging review process and oversight, the compound produced supportive efficacy data and received accelerated FDA approval, delivering a new treatment option for patients with bladder cancer.