The FDA has approved Lorbrena (lorlatinib, Pfizer Inc.) for patients with anaplastic lymphoma kinase- (ALK)-positive metastatic non-small cell lung cancer (NSCLC) that have progressed on prior therapies.
Lung cancer is the main cause of cancer deaths worldwide. NSCLC accounts for about 85 percent of lung cancers; it is difficult to treat, and exceptionally aggressive. Close to 75 percent of patients with NSCLC are diagnosed late with metastatic or advanced cancer. Although many patients with ALK-positive metastatic NSCLC respond to initial tyrosine kinase inhibitor (TKI) therapy, their tumors tend to progress. And for patients who progress after treatment with such second-generation TKIs as alectinib, brigatinib and ceritinib, there are limited options. Lorlatinib has been developed specifically to restrain such tumor variations, which may cause resistance to other TKIs.
The FDA gave the go-ahead under an accelerated approval based on tumor response rate and duration of response. Although lorlatinib has been approved, its continued approval may depend upon verification and clinical benefits in a confirmatory clinical trial.