Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Lorbrena (lorlatinib) for previously-treated ALK-positive metastatic non-small cell lung cancer (NSCLC).
Lorbrena is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to treat patients with ALK-positive metastatic 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.
Pfizer Oncology global president Andy Schmeltz said: “Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumor complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors.
“We believe that Lorbrena will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”
The FDA has approved Lorbrena based on results of a non-randomized, dose-ranging and activity-estimating, multi-cohort and multicenter phase 1/2 study.
The trial assessed Lorbrena to treat patients with ALK-positive metastatic NSCLC, who were earlier treated with one or more ALK TKIs.
Pfizer recruited 215 patients with ALK-positive metastatic NSCLC across various subgroups based on prior treatment in the study.
At present, Lorbrena secured approval in Japan to treat of ALK fusion gene-positive unresectable advanced and/or recurrent non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitor(s).
Pfizer oncology global product development chief development officer Dr Mace Rothenberg said: “Since leading with the first approval of a biomarker-driven treatment for ALK-positive non-small cell lung cancer in 2011, Pfizer scientists and clinicians have remained committed to researching and developing medicines that can further advance the care of these patients.”
In 2011, Pfizer launched Xalkori (crizotinib) as the first TKI to treat ALK-positive metastatic NSCLC. Xalkori is a TKI to treat patients with metastatic NSCLC whose tumors are ALK or ROS1-positive as detected by an FDA-approved test.