v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 6bae4b7b0768…
Confirmed unchanged at annual review; wording consistent with approved label
Veraxanib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic fibroblast growth factor receptor 2 (FGFR2)-altered solid tumours that have progressed following at least one prior line of systemic therapy and for which there are no satisfactory alternative treatment options. A companion diagnostic device is required to confirm tumour FGFR2 alteration status prior to initiating treatment with Veraxanib (see section 4.4).
v2
Dr. A. Müller (MAH Medical Affairs) · 12 Sept 2023 · 6bae4b7b0768…
Updated to specify "at least one prior line" per CHMP Day 120 list of questions; CDx requirement added
Veraxanib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic fibroblast growth factor receptor 2 (FGFR2)-altered solid tumours that have progressed following at least one prior line of systemic therapy and for which there are no satisfactory alternative treatment options. A companion diagnostic device is required to confirm tumour FGFR2 alteration status prior to initiating treatment with Veraxanib (see section 4.4).
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 1efb8606fb1b…
Initial indication wording from clinical submission
Veraxanib is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic fibroblast growth factor receptor 2 (FGFR2)-altered solid tumours that have progressed following prior therapy and for which there are no satisfactory alternative treatment options.