Pfizer’s new lung cancer treatment Lorbrena has bagged US approval for previously treated patients with a specific gene mutation and metastatic disease.
Lorbrena (lorlatibin) has been cleared to treat ALK-positive metastatic non-small cell lung cancer in patients 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.
The drug was cleared under accelerated approval based on tumor response rate and duration of response, and so continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial, the firm stressed.
Lorbrena is a third-generation ALK tyrosine kinase inhibitor (TKI).
According to Pfizer, while many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, they typically experience tumor progression, and additional options for those who progress after treatment with second-generation ALK TKIs are limited.
“In a clinical study which included patients with or without brain metastases,Lorbrena demonstrated clinical activity in patients with metastatic ALK-positive non-small cell lung cancer who had failed other ALK biomarker-driven therapies,” said Alice Shaw, Professor of Medicine at Harvard Medical School, and director of the Center for Thoracic Cancers at Massachusetts General Hospital.
The non-randomised, dose-ranging and activity-estimating Phase I/II study showed an overall response rate of 48%. Sixty-nine percent of patients had a history of brain metastases and intracranial response rate was 60%.