Data from Pharmawand - Curated by EPG Health - Date added 13 February 2018
Pfizer Inc. announced that the FDA accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. Lorlatinib is an investigational, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK TKIs.
The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. In April 2017, lorlatinib received Breakthrough Therapy Designation from the FDA for patients with ALK-positive metastatic NSCLC previously treated with one or more ALK inhibitors. The submissions are based on Phase II data from a Phase 1/II clinical trial (NCT01970865) of lorlatinib, evaluating patients treated in distinct cohorts based on prior therapy. Full results from the Phase II portion of the trial were presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in October 2017. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2018.