ODAC Cautiously Backs Keytruda in Early Bladder Cancer
Ser en ganske interessant formulering her:
FDA’s guidance for developing new drugs in this setting notes that “a high [CR] rate is not meaningful if the response duration is short.” Randomized trials using placebo as a comparator are considered unethical – as such, the agency has allowed single-arm registration trials in this setting. Recommendations from the International Bladder Cancer Group (IBCG) call for a 30% CR rate at 12 months, while the American Urological Association (AUA) has called for a 30% CR rate at 18 to 24 months.
“This did not get close to those benchmarks – not close,” said Pavlovich. “That very much affected me in terms of my voting.”
EDIT: Jeg tenker at det trenger ikke være automatikk i at FDA gir approval når Keytruda ikke er nær benchmark-kravene