FDA Accepts and Grants Priority Review for Xalkori

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FDA granted priority review status for XALKORI for the treatment of patients with NSCLC with ROS1-positive tumors.

On Dec. 8, 2015 Pfizer Inc. announced FDA accepted and granted Priority Review for a supplemental new drug application (sNDA) for Xalkori (crizotinib) for the treatment of patients with metastic non-small cell lung cancer (NSCLC) with ROS1-postive tumors. Priority Review status will accelerate FDA review time of Xalkori from 10 months, to a goal of six months from the day of acceptance of filing.

Xalkori is currently indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive. In April 2015, Xalkori received Breakthrough Therapy designation from FDA for treatment of patients with ROS1-positive NSCLC. If approved, Xalkori would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC. The projected FDA action date is April 2016.

“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,” said Mace Rothenberg, MD, senior vice-president of Clinical Development and Medical Affairs and CMO for Pfizer Oncology, in a 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.”

ROS1 rearrangement occurs when the ROS1 gene attaches to another gene and changes the way the genes function, a phenomenon which is thought to contribute to cancer-cell growth. A study published in The Oncologist, suggests that ROS1 rearrangements occur in approximately one percent of NSCLC cases. Of the estimated 1.5 million new cases of NSCLC worldwide each year, roughly 15,000 may be driven by oncogenic ROS1 fusions.


The submission to FDA is based on data from a multicenter, single-arm Phase I study that evaluated Xalkori in 53 patients with ROS1-positive metastatic NSCLC. Data from 50 of these patients showed that Xalkori exhibited marked anti-tumor activity in patients with ROS1-positive metastatic NSCLC.

Source: Pfizer Inc.