Cohort 3 of the phase 2 TROPHY-U-01 trial evaluated sacituzumab govitecan plus pembrolizumab in checkpoint inhibitor-naive adults with metastatic urothelial cancer who progressed after platinum-based chemotherapy.
The NDA submission included data from 36 clinical trials involving over 8000 patients.
The phase 3 LEAP-011 study evaluated pembrolizumab plus lenvatinib vs placebo in 441 adults with histologically confirmed, locally advanced or metastatic urothelial carcinoma.
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.
The phase 3 CERTAIN-1 study compared the efficacy and safety of cefepime-taniborbactam to meropenem in 661 adults with cUTI.
The CRL stated that the application for bardoxolone could not be approved in its current form due to a lack of data supporting claims of slowing kidney function loss and reducing kidney failure progression.
In the CRL, the FDA stated that a satisfactory inspection is required before the NDA can be approved.
Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist.
Kyzatrex is an investigational, oral testosterone undecanoate softgel that utilizes lymphatic absorption and phytosterols to increase bioavailability and provide a favorable pharmacokinetic profile.
