FDA approves new indication for Pfizer cancer drug

July 15, 2022

The U.S. FDA has approved Pfizer’s crizotinib — branded as Xalkori — for the treatment of unresectable, recurrent or refractory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors in patients aged one and older.

The approval followed the assessment of two multicenter, single-arm, open-label trials — ADVL0912, which enrolled 14 pediatric patients and A8081013, in which 7 adult patients participated.

Xalkori is a kinase inhibitor that works by inhibiting ALK, and other growth factor receptors associated with unchecked cell proliferation that leads to tumors. Because most patients with NSCLC have genetic mutations, the drug helps decrease the reproduction of cells carrying the gene.

The drug was first approved in 2011 and has the FDA green light to treat metastatic non-small cell lung cancer in patients whose tumors are positive for ALK or ROS1 mutations, as well as for ALK-positive anaplastic large cell lymphoma in children and young adults.