|
SMC2867
|
07/09/2026
|
lorlatinib (Lorviqua)
|
Reassessment
|
As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor or whose disease has progressed after prior treatment with an ALK inhibitor.
|
|
|
SMC2941
|
08/06/2026
|
nintedanib (Ofev)
|
Non submission
|
Indicated in children and adolescents from 6 to 17 years old for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs). Indicated in adults, adolescents and children aged 6 years and older for the treatment of systemic sclerosis associated interstitial lung disease (SSc-ILD).
|
|
|
SMC2834
|
11/05/2026
|
amivantamab (Rybrevant)
|
Full
|
In combination with lazertinib for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations.
|
|
|
SMC2818
|
11/05/2026
|
durvalumab (Imfinzi)
|
Full
|
Treatment of adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
|
|
|
SMC2815
|
13/04/2026
|
osimertinib (Tagrisso)
|
Full
|
For treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy.
|
|
|
SMC2840
|
19/01/2026
|
serplulimab (Hetronifly)
|
Full
|
In combination with carboplatin and etoposide for the first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC).
|
|
|
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
|
|
|
SMC2816
|
10/11/2025
|
tarlatamab (Imdylltra)
|
Full
|
Treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after at least two prior lines of therapy including platinum-based chemotherapy.
|
|
|
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.
|
|
|
SMC2865
|
08/09/2025
|
encorafenib (Braftovi®)
|
Non submission
|
In combination with binimetinib for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
|
|
|
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.
|
|
|
SMC2749
|
07/04/2025
|
alectinib hydrochloride (Alecensa)
|
Full
|
Monotherapy as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection.
|
|
|
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).
|
|
|
SMC2734
|
10/02/2025
|
durvalumab (Imfinzi)
|
Abbreviated
|
in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
|
|
|
SMC2677
|
09/12/2024
|
durvalumab (Imfinzi)
|
Full
|
In combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy after surgery, is indicated for the treatment of adults with resectable (tumours ≥ 4 cm and/or node-positive) NSCLC and no known EGFR mutations or ALK rearrangements.
|
|
|
SMC2688
|
11/11/2024
|
pembrolizumab (Keytruda)
|
Full
|
In combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for the treatment of resectable non‑small cell lung carcinoma at high risk of recurrence in adults.
|
|
|
SMC2724
|
07/10/2024
|
cemiplimab (Libtayo)
|
Non submission
|
In combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: - locally advanced NSCLC who are not candidates for definitive chemoradiation, or - metastatic NSCLC
|
|
|
SMC2689
|
07/10/2024
|
pembrolizumab (Keytruda)
|
Full
|
As monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.
|
|
|
SMC2706
|
12/08/2024
|
trastuzumab deruxtecan (Enhertu)
|
Non submission
|
As monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
|
|
|
SMC2638
|
11/12/2023
|
amivantamab (Rybrevant)
|
Non submission
|
As monotherapy for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.
|
|