Mise à jour 5 octobre 2025

Erdafitinib

Bladder / Métastatique

Québec / Canada

7 an.

positive 10 mai 2025

7 an.

positive 20 janvier 2018

positive 5 février 2025

positive 28 janvier 2025

in-progress

in-progress

Comparaison avec les autres pays

Canada

Canada

14 mois

positive 20 janvier 2018

Health Canada

États-Unis

États-Unis

5 an.

positive 12 avril 2019

FDA approval

Europe

Europe

positive 27 juin 2024

EMA approval

Reimbursement is post at least one treatment that included an IO.

If IO was given in neoadjuvant or adjuvant, disease progression had to occur within 12 months.

There has been no application for approval for IO naive pretreated patients as per the Cohort 2 of THOR trial. With availability of EV+Pembro in first line, this approval is not relevant to practice.

Testing is encouraged for all patients and not wait until progression to avoid missing rapid progressors.

The use of Erdafitinib post IO showed that it is safe and we would not have to go through a washout period, yet surveillance of toxicities for Erdafitinib is warranted especially occular toxicity.

Sequencing of Erdafitinib and EV has not been fully explored in randomized trials, however we have some retrospective data from the UNITE database showing good efficacy and the use of both agents is associated with longer survival when feasible than using EV alone in FGFR2/3 alt aUC.

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