This article is more than 5 years old. Information may no longer be current.
FDA grants priority review to Xalkori for new indication in NSCLC
Click Here to Manage Email Alerts
The FDA granted priority review to a supplemental new drug application for crizotinib.
Crizotinib (Xalkori, Pfizer) — a kinase inhibitor — already is approved for treatment of patients with metastatic ALK-positive non–small cell lung cancer.
The supplemental application requests that the approval be expanded to allow crizotinib to be used for treatment of patients with metastatic ROS1-positive NSCLC. The FDA granted breakthrough therapy designation to crizotinib for this indication in April.
ROS1 rearrangement occurs in an estimated 1% of NSCLC cases, according to a Pfizer-issued press release.
“ROS1 represents the second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumor activity that can potentially make a meaningful difference for patients,” Mace Rothenberg, MD, chief medical officer for Pfizer Oncology, said in the press release. “The development of Xalkori in this subgroup of patients is an example of the capability of precision medicine to identify treatments for patients whose tumors contain rare genetic mutations, such as ROS1-positive metastatic NSCLC.”
The supplemental application is based on results of a multicenter, single-arm phase 1 study in which researchers evaluated crizotinib in 53 patients with metastatic ROS1-positive NSCLC. The agent demonstrated anti-tumor activity in this population, and the drug’s safety profile appeared consistent with that observed in patients with metastatic ALK-positive NSCLC.
The FDA is expected to make a decision on the supplemental application by April.