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LAZCLUZE (Janssen-Cilag Pty Ltd)
Product name
LAZCLUZE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
214 (255 working days)
Active ingredients
lazertinib mesilate monohydrate
Registration type
NCE/ NBE
Indication
LAZCLUZE in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.