FDA Grants Lorlatinib Breakthrough Therapy Designation for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On April 27, the investigational next-generation ALK/ROS1 tyrosine kinase inhibitor lorlatinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) previously treated with one or more ALK inhibitors.
Breakthrough Therapy Designation
Enacted as part of the 2012 FDA Safety and Innovation Act, Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.
“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,” said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. “We look forward to working with the FDA to accelerate the development of this therapy.”
The Breakthrough Therapy designation is supported by the efficacy and safety data of an ongoing phase I/II clinical trial of lorlatinib, which includes patients with ALK-positive NSCLC who were previously treated with one or more ALK inhibitors.
Additionally, the phase III CROWN study recently began enrolling patients. CROWN is an ongoing, open label, randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC.
About Lorlatinib
Lorlatinib is an investigational next-generation ALK/ROS1 tyrosine kinase inhibitor that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1. Lorlatinib was specifically designed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood-brain barrier.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
