|
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.
|
|
|
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%
|
|
|
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.
|
|
|
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.
|
|
|
SMC2094
|
08/10/2018
|
ipilimumab (Yervoy)
|
Abbreviated
|
Treatment of advanced (unresectable or metastatic) melanoma in adolescents 12 years of age and older.
|
|
|
1087/15
|
12/12/2016
|
pembrolizumab (Keytruda)
|
Resubmission
|
As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously treated with ipilimumab.
|
|
|
1187/16
|
07/11/2016
|
nivolumab (Opdivo)
|
Full
|
In combination with ipilimumab for the treatment of advanced (unresectable or metastatic) melanoma in adults.
|
|
|
1086/15
|
09/11/2015
|
pembrolizumab (Keytruda)
|
Full
|
As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. This submission relates to use in adults previously untreated with ipilimumab.
|
|
|
997/14
|
10/11/2014
|
ipilimumab (Yervoy)
|
Full
|
Treatment of advanced (unresectable or metastatic) melanoma in adults (first-line use).
|
|
|
779/12
|
08/04/2013
|
ipilimumab (Yervoy)
|
Resubmission
|
For the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.
|
|
