FDA accelerated approval of Lorbrena for lung cancer indication

The US Food and Drug Administration has approved Lorbrena (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI).

Developed by US pharma giant Pfizer (NYSE: PFE), Lorbrena is indicated 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 tumor response rate and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial, noted Pfizer. This represents the third FDA approval Pfizer has received for an oncology treatment, including two lung cancer medicines, within two months.