Pfizer announced that lorlatinib has been granted Breakthrough Therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who were previously treated with one or more ALK inhibitors.

Lorlatinib is a next-generation ALK/ROS1 tyrosine kinase inhibitor. ALK gene rearrangement can drive the development of lung cancer in some patients, with tumor mutations a particular challenge in disease progression for patients with ALK-positive metastatic NSCLC.

Commenting on the FDA’s decision, Mace Rothenberg, MD, and CDO of Pfizer Oncology said, “This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK-positive NSCLC whose cancers have progressed despite treatment. We look forward to working with the FDA to accelerate the development of this therapy.” 

Related Articles

Date from an ongoing Phase 1/2 clinical trial of loratinib – in patients with ALK-positive NSCLC previously treated with one or more ALK inhibitors – supports the FDA’s decision to designate the therapy as Breakthrough.

Pfizer has begun enrolling patients in a Phase 3 study of lorlatinib, called ‘CROWN’. The trial will be an open-label randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC. 

For more information visit