We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » New FDA Guidance Outlines Trial Design for BCG-Unresponsive NMIBC Drugs
New FDA Guidance Outlines Trial Design for BCG-Unresponsive NMIBC Drugs
Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said in a final guidance that is not significantly different from the agency’s 2016 draft.