|
SMC2915
|
09/03/2026
|
pembrolizumab (Keytruda®)
|
Non submission
|
In combination with pemetrexed and platinum chemotherapy for the first‑line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma
|
|
|
SMC2878
|
08/12/2025
|
amivantamab (Rybrevant)
|
Resubmission
|
In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations
|
|
|
SMC2736
|
07/07/2025
|
osimertinib (Tagrisso)
|
Full
|
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
|
|
|
SMC2768
|
10/03/2025
|
amivantamab (Rybrevant)
|
Non submission
|
In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
|
|
|
SMC2207
|
07/10/2019
|
pembrolizumab (Keytruda)
|
Resubmission
|
In combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
|
|
|
770/12
|
08/12/2014
|
pemetrexed (Alimta)
|
Full
|
monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
|
|
|
642/10
|
11/10/2010
|
pemetrexed (Alimta)
|
Full
|
Non-small cell lung cancer
|
|
|
531/09
|
08/02/2010
|
pemetrexed (Alimta)
|
Resubmission
|
first line treatment of patients with locally advanced or metastatic non-small cell lung cancer
|
|
|
342/07
|
08/09/2008
|
pemetrexed (Alimta)
|
Resubmission
|
monotherapy for second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
|
|
|
342/07
|
12/02/2007
|
pemetrexed, 500mg, powder for reconstitution (Alimta)
|
Full
|
Locally advanced or metastatic non-small cell lung cancer.
|
|
|
268/06
|
08/05/2006
|
Pemetrexed (Alimta)
|
Non submission
|
Locally advanced or metastatic non-small cell lung cancer after prior chemotherapy
|
|
|
192/05
|
08/08/2005
|
Pemetrexed 500mg infusion (Alimta®)
|
Full
|
Chemotherapy-naïve patients with unresectable malignant pleural mesothelioma
|
|