Pfizer has received approval from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Xalkori (crizotinib) to treat patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).

Xalkori is said to be the first and only FDA-approved biomarker-driven therapy for metastatic NSCLC whose tumours have an ROS-1 gene alteration.

This oral medication is claimed to block the activity of the ROS-1 protein in tumours that have ROS-1 gene alterations. This effect on ROS-1 may prevent NSCLC from growing and spreading, FDA said.

ROS-1 gene alterations, which are believed to lead to abnormal cells, have been identified in various cancers, including NSCLC.

The rearrangements of ROS1 genes occur when one gene attaches to another and changes the way each normally functions, which can contribute to cancer-cell growth.

These alterations are present in approximately 1% of patients with NSCLC. The patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase (ALK) gene alterations, for which crizotinib use was previously approved.

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Xalkori was earlier approved in 2011 to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene.

"Today’s approval of XALKORI for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options."

Pfizer oncology chief medical officer Dr. Mace Rothenberg said: "Today’s approval of XALKORI for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options.

"As the only FDA-approved biomarker-driven therapy that includes two distinct molecular targets in metastatic NSCLC, ROS1 and ALK, XALKORI exemplifies our commitment to precision drug development and to identifying the right treatment for the right patient."

The FDA approval is based on the Phase 1 study (Study 1001), which included 50 patients with ROS1-positive metastatic NSCLC treated with 250 mg of Xalkori orally twice daily.

The multicentre, single-arm study evaluated the efficacy of Xalkori in patients with ROS1-positive metastatic NSCLC.

Image: Pfizer world headquarters in New York City. Photo: courtesy of Norbert Nagel.