Qualifying Notice - Lumakras (English, HTML)

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Publisher-reported update

2023-11-02

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Lumakras (sotorasib), control number 248435, for the indication of the treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, qualifies to be considered for authorization in accordance with the NOC/c Guidance.

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