|
SMC2820
|
19/01/2026
|
nivolumab (Opdivo)
|
Full
|
In combination with ipilimumab (YERVOY®) (NIVO + IPI) is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) colorectal cancer (CRC) in the following settings: first-line treatment of unresectable or metastatic CRC.
|
|
|
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
|
|
|
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.
|
|
|
SMC2589
|
15/01/2024
|
pembrolizumab (Keytruda)
|
Full
|
As monotherapy for the treatment of the following MSI H or dMMR tumours in adults with:
- unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy;
- advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;
- unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
|
|
|
SMC2562
|
09/10/2023
|
regorafenib (Stivarga)
|
Full
|
Adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies
|
|
|
SMC2394
|
13/12/2021
|
nivolumab (Opdivo)
|
Full
|
nivolumab with ipilimumab (NIVO+IPI) is indicated for the treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based combination chemotherapy.
|
|
|
SMC2375
|
13/09/2021
|
pembrolizumab (Keytruda)
|
Full
|
As monotherapy for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
|
|
|
SMC2312
|
10/05/2021
|
encorafenib (Braftovi)
|
Full
|
In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic 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.
|
|
|
1082/15
|
13/07/2015
|
panitumumab (Vectibix)
|
Non submission
|
Treatment of adult patients with wild-type RAS metastatic colorectal cancer first-line in combination with FOLFIRI.
|
|
|
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.
|
|
|
878/13
|
10/03/2014
|
aflibercept (Zaltrap)
|
Resubmission
|
In combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy, aflibercept is indicated in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
|
|
|
769/12
|
13/02/2012
|
panitumumab (Vectibix)
|
Non submission
|
Metastatic colorectal cancer (mCRC)
|
|
|
543/09
|
08/02/2010
|
cetuximab (Erbitux)
|
Resubmission
|
Metastatic colorectal cancer
|
|
|
543/09
|
14/04/2009
|
cetuximab (Erbitux)
|
Full
|
Epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer
|
|
|
507/08
|
13/10/2008
|
capecitabine (Xeloda)
|
Full
|
Metastatic colorectal cancer
|
|
|
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
|
|
|
404/07
|
08/10/2007
|
ertapenem (Invanz)
|
Full
|
for the prophylaxis of surgical site infection following elective colorectal surgery in adults.
|
|
|
221/05
|
05/06/2006
|
bevacizumab (Avastin)
|
Resubmission
|
Metastatic colorectal cancer
|
|