|
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.
|
|