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SMC ID Date Medicine Submission Type Indication
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.
SMC2012 13/08/2018 alectinib hydrochloride (Alecensa) Full As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
1257/17 08/05/2017 alectinib hydrochloride (Alecensa) Non submission As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib.

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