LORVIQUA (Pfizer Australia Pty Ltd)
Product name
LORVIQUA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
197 working days (255)
Active ingredients
lorlatinib
Registration type
NCE/NBE
Indication
LORVIQUA (tablets) has provisional approval in Australia for the treatment of patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) whose disease has progressed on:
- crizotinib and at least one other ALK inhibitor; or
- alectinib as the first ALK inhibitor therapy; or
- ceritinib as the first ALK inhibitor therapy.
The decision to approve this indication has been made on the basis of tumour response rate and duration of response in a single arm study. Continued approval of this indication depends on verification and description of benefit in a confirmatory trial.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration