Posted by Michael Wonder on 04 Nov 2018
U.S. FDA approves Lorbrena (lorlatinib) for previously treated ALK-positive metastatic non-small cell lung cancer
2 November 2018 - Lorbrena addresses unmet needs for certain patients treated with prior ALK therapy.
Pfizer today announced that the U.S. FDA has approved Lorbrena (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This represents the third FDA approval Pfizer has received for an oncology treatment, including two lung cancer medicines, within two months.
The approval was based on a non-randomised, dose-ranging and activity-estimating, multi-cohort, multi-centre Phase 1/2 study, B7461001, evaluating Lorbrena for the treatment of patients with ALK-positive metastatic NSCLC, who were previously treated with one or more ALK TKIs. A total of 215 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups based on prior treatment.
