Erdafitinib (1) – Balversa®

a1) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are suitable for cisplatin-containing chemotherapy and have not yet received it; second-line treatment

• An additional benefit is not proven.
• The data from the THOR study are not suitable for assessing additional benefit. In the control arm of Cohort 1, patients were treated with chemotherapy (vinflunine or docetaxel). This does not correspond to the appropriate comparator therapies for patient groups a1 and b. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.

a2) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are not suitable for cisplatin-containing chemotherapy; second-line treatment

• The additional benefit is not proven.
• The active ingredients vinflunine and docetaxel, used in the comparator arm of Cohort 1, represent – alongside paclitaxel – the appropriate comparator therapy for the patient population. However, not all patients in Cohort 1 represent the patient population a2.
• Irrespective of this, the exact proportion of patients who were treated in accordance with the appropriate comparator therapy cannot be determined on the basis of the data provided.
• As part of the commenting procedure, the pharmaceutical manufacturer submitted, amongst other things, analyses of the total population of Cohort 1. However, these do not allow any conclusions to be drawn regarding patient population a2, as not all patients in Cohort 1 represent patient population a2. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.

b) Adults with unresectable or metastatic urothelial carcinoma exhibiting specific genetic alterations in FGFR3, following prior treatment with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor at the unresectable or metastatic stage, and who are suitable for chemotherapy; third-line treatment

• The additional benefit is not proven.
• The data from the THOR study are not suitable for assessing additional benefit. In the control arm of Cohort 1, patients were treated with chemotherapy (vinflunine or docetaxel). This does not correspond to the appropriate comparator therapies for patient groups a1 and b. There are therefore no suitable data available for an assessment of the additional benefit of erdafitinib.

Courtesy translation only, please refer to the German original.