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SMC ID Date Medicine Submission Type Indication
SMC2910 13/07/2026 tebentafusp (Kimmtrak) Resubmission

For treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma.

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.

SMC2874 13/10/2025 nivolumab (Opdivo) Non submission

In combination with platinum-based chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgical resection, for the treatment of adults with resectable (tumours ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements.

SMC2726 07/10/2024 nivolumab (Opdivo) Non submission

In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

SMC2704 12/08/2024 nivolumab (Opdivo) Non submission

Adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma.

SMC2645 08/07/2024 nivolumab / relatlimab (Opdualag) Full

For treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and over.

SMC2619 11/12/2023 nivolumab (Opdivo) Full

In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer in adults.

SMC2620 11/09/2023 nivolumab (Opdivo) Non submission

In combination with ipilimumab for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell programmed death ligand (PD-L1) expression ≥ 1%

SMC2519 12/06/2023 nivolumab (Opdivo) Full

in combination with fluoropyrimidine- and platinum-based combination chemotherapy, for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.

SMC2503 13/02/2023 nivolumab (Opdivo) Full

For the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

SMC2458 12/09/2022 nivolumab (Opdivo) Full

In combination with fluoropyrimidine and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.

SMC2429 09/05/2022 nivolumab (Opdivo) Full

As monotherapy is indicated for the adjuvant treatment of adult patients with completely resected oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.

SMC2385 07/02/2022 nivolumab (Opdivo) Full

In combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

SMC2397 17/01/2022 nivolumab (Opdivo) Full

In combination with ipilimumab and 2 cycles of platinum-based doublet chemotherapy (PDC) is indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations.

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.

SMC2386 11/10/2021 cabozantinib (Cabometyx) Abbreviated

in combination with nivolumab for the first-line treatment of advanced renal cell carcinoma in adults

SMC2362 09/08/2021 nivolumab (Opdivo) Full

As monotherapy for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum-based combination chemotherapy

SMC2153 10/06/2019 nivolumab (Opdivo) Full In combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma.
SMC2112 10/12/2018 nivolumab (Opdivo) Full as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
1285/18 15/01/2018 nivolumab (Opdivo) Full

As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

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Publication due date SMC meeting date Medicine Submission Type Indication
TBC TBC nivolumab (Opdivo) Full

Nivolumab in combination with ipilimumab is indicated for the first‑line treatment of adult patients with unresectable or advanced hepatocellular carcinoma