Panitumumab
Panitumumab (Vectibix, Amgen Europe B.V.) has 3 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Colorectal cancer3 | |||
Wild-type RAS | + FOLFOX or FOLFIRI | 1L metastatic | None |
Wild-type RAS | + FOLFIRI | 2L metastatic | After first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) |
Wild-type RAS | Monotherapy | 3L+ metastatic | Failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens |
Full text of section 4.1 (therapeutic indications)
Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): • in first-line in combination with FOLFOX or FOLFIRI. • in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). • as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Label history
43 changes to the Vectibix label since 2008, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes