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SMC ID Date Medicine Submission Type Indication
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
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