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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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Publication due date SMC meeting date Medicine Submission Type Indication
TBC TBC tegafur / gimeracil / oteracil (Teysuno) Full

As monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer (mCRC) for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome (HFS) or cardiovascular toxicity (CVT) that developed in the adjuvant or metastatic setting.