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SMC ID Date Medicine Submission Type Indication
SMC2621 11/09/2023 crizotinib (Xalkori) Non submission

As monotherapy for the treatment of paediatric patients (age ≥6 to <18 years) with:

  • relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL)
  • recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)
SMC2147 10/06/2019 brigatinib (Alunbrig) Full

as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib
1329/18 11/06/2018 crizotinib (Xalkori) Full Treatment of adults with ROS1-positive advanced non-small cell lung cancer.
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.
1152/16 11/07/2016 crizotinib (Xalkori) Full First-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
1097/15 07/12/2015 ceritinib (Zykadia) Full Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.
865/13 07/10/2013 crizotinib (Xalkori) Resubmission For the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

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