Posted by Michael Wonder on 27 Apr 2017
Pfizer's next generation ALK/ROS1 inhibitor lorlatinib, granted breakthrough therapy designation from FDA for ALK positive metastatic non-small-cell lung cancer
27 April 2017 - Pfizer today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted breakthrough therapy designation from the U.S. FDA for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer, previously treated with one or more ALK inhibitors.
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. ALK gene rearrangement is a genetic alteration that drives the development of lung cancer in some patients.
