Nonmuscle Invasive Bladder Cancer Guidance

FDA has issued a draft guidance, BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment, to assist sponsors in the clinical development of drugs, including biologics, to treat patients who have bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). The document says that many of its principles also apply to developing drugs for other forms of NMIBC. However, it says, the specific recommendations for trial design and endpoints in it may not necessarily apply, and it encourages sponsors to discuss development plans with FDA for drugs intended to treat other forms of NMIBC or for muscle invasive, locally advanced, or metastatic bladder cancer. The guidance does not discuss the general issues of statistical analysis or clinical trial design that are covered in International Council on Harmonization guidances.