I find this FDA decision quite surprising. While we should welcome it, I think we should also approach it with caution. Essentially, this is just a regulatory decision: the FDA has expanded Anktiva’s indication from patients in BCG-unresponsive NMIBC with CIS and with or without concomitant papillary tumors, to include patients with high-grade papillary-only in BCG -unresponsive patients settings. However, this expansion was not based on direct evidence of efficacy from a separate clinical trial specifically evaluating Anktiva in patients with papillary-only disease. Rather, it relies on extrapolating efficacy from the population with CIS. The FDA’s rationale is that, although CIS and papillary urothelial carcinoma differ in their architectural growth patterns, both are considered aggressive urothelial carcinomas. They can coexist in the same patient, may be difficult to distinguish pathologically, and are associated with substantial risks of recurrence and progression in the BCG-unresponsive setting. This is a noteworthy regulatory decision: the FDA has accepted an expansion of the indication based on extrapolation from the old evidence supporting the original approval for CIS, rather than requiring a new clinical trial to demonstrate efficacy directly in patients with papillary-only disease. And please keep in mind that FDA approval for use in a particular patient population does not necessarily mean that efficacy has been directly demonstrated in that specific population through clinical trials. @UroDocAsh , @LauraBukavinaMD , @MaxKates