|
SMC2858
|
13/10/2025
|
fruquintinib (Fruzaqla)
|
Resubmission
|
For the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-VEGF therapy, and, if RAS wildtype and medically appropriate, an anti-EGFR therapy
|
|
|
SMC2812
|
09/06/2025
|
pegylated liposomal irinotecan (Onivyde)
|
Non submission
|
In combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas
|
|
|
SMC2654
|
12/08/2024
|
trifluridine tipiracil (Lonsurf)
|
Full
|
In combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.
|
|
|
1217/17
|
13/03/2017
|
liposomal irinotecan (Onivyde)
|
Full
|
Treatment of metastatic adenocarcinoma of the pancreas, in combination with fluorouracil (5-FU) and leucovorin (folinic acid), in adult patients who have progressed following gemcitabine based therapy.
|
|
|
1221/17
|
13/02/2017
|
trifluridine/tipiracil (Lonsurf)
|
Full
|
for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.
|
|
|
1156/16
|
09/05/2016
|
ramucirumab (Cyramza)
|
Non submission
|
In combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) for the treatment of adult patients with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
|
|
|
1012/14
|
12/01/2015
|
cetuximab (Erbitux)
|
Full
|
Treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer: in combination with irinotecan-based chemotherapy; in first-line in combination with FOLFOX; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
|
|
|
769/12
|
13/02/2012
|
panitumumab (Vectibix)
|
Non submission
|
Metastatic colorectal cancer (mCRC)
|
|
|
486/08
|
09/06/2008
|
panitumumab 20mg/ml concentrate for solution for infusion (Vectibix)
|
Non submission
|
as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma
|
|
|
221/05
|
05/06/2006
|
bevacizumab (Avastin)
|
Resubmission
|
Metastatic colorectal cancer
|
|
|
155/05
|
10/10/2005
|
cetuximab (Erbitux)
|
IRP
|
In combination with irinotecan for the treatment of patients with epidermal growth factor receptor expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy
|
|
