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Lorviqua
Published
Product name
Lorviqua
Active ingredient
Lorlatinib
Submission type
New chemical entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Lorviqua (lorlatinib) was provisionally approved for the following therapeutic use:
Lorviqua 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.
The provisional registration period for the above medicine is two years starting on the day specified in the ARTG certificate of registration.
How this medicine works
Lorlatinib is an adenosine triphosphate (ATP)-competitive, brain-penetrant, small molecule inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) tyrosine kinases that addresses mechanisms of resistance following previous treatment with ALK inhibitor therapy.In nonclinical studies, lorlatinib inhibited catalytic activities of non-mutated ALK and a broad range of clinically relevant ALK mutant kinases in recombinant enzyme and cell-based assays. The ALK mutations analyzed included those conferring resistance to other ALK inhibitors, including alectinib, brigatinib, ceritinib, and crizotinib.Lorlatinib demonstrated anti-tumour activity at nanomolar free plasma concentrations in mice bearing tumor xenografts that express echinoderm microtubule-associated protein-like 4 (EML4) fusions with ALK variant 1 (v1), including ALK mutations L1196M, G1269A, G1202R, and I1171T. Two of these ALK mutants, G1202R and I1171T, are known to confer resistance to first and second generation ALK inhibitors. Lorlatinib is also capable of penetrating the blood-brain barrier and achieved efficacious brain exposure in mice and rat. In mice bearing orthotopic EML4-ALK or EML4-ALKL1196M brain tumour implants, lorlatinib caused tumour shrinkage and prolonged survival. The overall anti-tumour efficacy of lorlatinib was dose-dependent and strongly correlated with inhibition of ALK phosphorylation.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Lorviqua was considered favourable for the therapeutic use approved.
Sponsor