FDA approves launch of Pfizer's third-generation ALK tyrosine kinase inhibitor Lorbrena

lung cancer is one of the leading causes of cancer death in the worldLung cancer kills more people each year than colon, breast and prostate cancer combinedRecently, PfizerInc(announced that the U.SFDA(approved the company's development of the third generation of ALK tyrosine kinase inhibitor (TKI) Lorbreib (Lorlatinib) for the treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) patientsthese patients continued to worsen after receiving crizotinib or at least one other ALK inhibitor, or after receiving alectinib or ceritinib as the first ALK inhibitor therapyThis is Pfizer's third cancer treatment approved by the FDA in the last two monthsLorbrenaLorbrena is the third generation of ALK TKI developed by PfizerIt showed high activity in tumors carrying alk and ROS1 chromosome recombinationin preclinical lung cancer modelstrialsLorbrena suppresses tumor mutations that are resistant to other ALK inhibitors and can cross the blood-brain barrierThedrug(a breakthrough therapy that has been approved by the FDA andnew drug(application sought for priority review)related studies
this approval is based on a non-random, dose-increasing, multi-cohort, multi-center phase 1/2 clinical studyIn the trial, called B7461001, 215 ALK-positive metastatic NSCLC patients were treatedThe total remission rate (ORR) of patients was 48% (95% CI: 42%, 55%)Importantly, 57% of patients have received more than one TYPE of ALK TKI treatmentIn this trial, 69 percent of patients had a history of brain metastatic tumors with an intracranial remission rate of 60 percent (95 percent CI 49 percent, 70 percent)As an expedited approval, Pfizer will continue to conduct validated clinical trials