Janssen Reports the MAA Submission of Erdafitinib to the EMA for Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations
Shots:
- The company submits the MAA to the EMA seeking approval of erdafitinib for adult patients with LA unresectable or metastatic UC harboring susceptible FGFR3 genetic alterations with disease progression during or following 1L containing PD-1/PD-L1 inhibitor
- The MAA was based on the results from cohort 1 of the P-III (THOR) study evaluating erdafitinib vs CT. The study met its 1EPs of OS & patients treated with erdafitinib achieved a m-OS of ~1yr. at the prespecified interim analysis. The safety profile was consistent with the prior reported safety profile of erdafitinib in mUC
- The US FDA has granted accelerated approval to erdafitinib in Apr 2019 as a targeted therapy for LA or mUC with susceptible FGFR3 or FGFR2 genetic alterations
Ref: Globenewswire | Image: Janssen
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