CORE-001 Trial Participation and Eligibility Criteria

The planned sBLA will seek approval of Anktiva for patients with BCG-unresponsive NMIBC in the papillary indication.

In this episode, Ashish M. Kamat, MD, MBBS, highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month.

“In this phase 2 study, an image-guided adaptive strategy enabled radiotherapy dose escalation to over 86% of patients’ bladder tumors without significant increase in toxicity,” wrote the authors.

“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.

Results from CREST will be presented at an upcoming medical conference.

"We expect to initiate patient dosing in the second quarter of this year, with initial three-month [complete response] data to follow," says Doug Warner.