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SMC ID Date Medicine Submission Type Indication
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.

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.

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.

SMC2382 17/01/2022 osimertinib (Tagrisso) Resubmission

As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

SMC2383 08/11/2021 osimertinib (Tagrisso) Full

Adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

1214/17 13/02/2017 osimertinib (Tagrisso) Full The treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer (NSCLC).

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