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RETEVMO (Eli Lilly Australia Pty Ltd)
Product name
RETEVMO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
181 (255 working days)
Active ingredients
selpercatinib
Registration type
NCE/NBE
Indication
RETEVMO has provisional approval for the treatment of adult patients with locally advanced or metastatic RET fusion positive non-small cell lung cancer (NSCLC).,The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response (DOR) from a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.