US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective

The role of PD-1/L1 diagnostics in immuno-oncology returned to headlines when the US FDA issued an alert on about lower efficacy in patients with low levels of PD-1/L1 expression in ongoing first-line bladder cancer Phase III trials of Tecentriq and Keytruda. FDA’s statement reinforces the agency’s emerging preference for providing prescribers with information about biomarker results while leaving labeled drug indications broad.

When FDA issued the safety alert May 18, the agency noted that labeling was not being changed for either drug. Both Keytruda and Tecentriq hold accelerated approval for first-line treatment...