TEPMETKO (Merck Healthcare Pty Ltd)
Product name
TEPMETKO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
88 (255 working days)
Active ingredients
tepotinib hydrochloride monohydrate
Registration type
NCE/NBE
Indication
TEPMETKO (film-coated tablet) has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition MET exon 14 skipping alterations.
The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.