April 7th 2025
A lookahead of the notable FDA decisions and conferences slated for Q2 2025.
Pembrolizumab, nadofaragene firadenovec lead the charge in BCG-unresponsive NMIBC
November 9th 2020“There is an urgent need for novel therapies in BCG-unresponsive disease. While standard cystectomy is highly curative, it is associated with a substantial risk for morbidity and non-trivial mortality,” said Arjun Balar MD.
FDA issues draft guidance for adjuvant trials in bladder cancer, renal cell carcinoma
October 2nd 2020"Currently, there is significant variability in the design, conduct, and analysis of clinical trials for adjuvant treatment of both kidney cancer and bladder cancer. This variability negatively affects our ability to interpret trial results," said Richard Pazdur, MD.
Avelumab frontline maintenance benefit sustained across subgroups in bladder cancer
September 29th 2020An analysis from the pivotal phase 3 JAVELIN Bladder 100 trial showed that the survival benefit observed with frontline maintenance avelumab in the overall population was sustained across several prespecified patients subgroups.