Shots:
- The US FDA has received an NDA for UGN-103 (mitomycin; intravesical) to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
- The NDA is supported by the P-III (UTOPIA) trial in adults with recurrent LG-IR-NMIBC, where UGN-103 achieved a 77.8% 3mos. CR rate & a 94.5% 6mos. DoR by Kaplan-Meier estimate, consistent with results from the pivotal ENVISION trial of Zusduri
- In Jan 2024, UroGen entered a licensing & supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC, building on Zusduri, an FDA-approved treatment for this patient population
Ref: Globenewswire | Image: Urogen | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
