AstraZeneca (AZN.L,AZN) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso or osimertinib to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer or NSCLC with activating epidermal growth factor receptor or EGFR mutations.
The recommendation is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.
The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 EU member countries plus Iceland, Norway and Liechtenstein. Earlier this month, Tagrisso was approved in the US for the 1st-line treatment of patients with metastatic NSCLC whose tumours have EGFR mutations (exon 19 deletions or exon 21 L858R mutations).
In addition to the EU, Tagrisso is under regulatory review in Japan for use in the 1st-line treatment setting with a decision anticipated in the second half of 2018. Other global health authority reviews and submissions are also ongoing.
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