The European Commission has approved Pfizer Inc's Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). In the European Union (EU), Xalkori is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC.

In March of this year, Xalkori was approved by the United States (US) Food and Drug Administration for patients with metastatic NSCLC whose tumors are ROS1-positive. With this approval, Xalkori becomes the only biomarker-driven therapy approved for patients with either ALK positive or ROS1-positive advanced NSCLC in the EU and US.

“The European Commission’s decision to approve Xalkori for ROS1-positive advanced NSCLC represents an important milestone for patients who previously had limited treatment options,” said Andreas Penk, MD, regional president, international developed markets, Pfizer Oncology. “We now know that NSCLC is not a single disease, but includes a number of molecularly defined tumors with different clinical characteristics and treatment options. With EU approvals in two distinct molecular targets in advanced NSCLC, ROS1 and ALK, Xalkori continues to break new ground and exemplify our commitment to precision drug development and patients.”

The European Commission’s approval of Xalkori in patients with ROS1-positive advanced NSCLC follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine’s Agency, and is supported by compelling results from a multicenter, single-arm phase 1 study (Study 1001) that included patients with ROS1-positive advanced NSCLC treated with 250 mg of Xalkori orally twice daily.

The efficacy outcome measure in this study was objective response rate (ORR) by RECIST. Secondary endpoints included time to tumor response (TTR), duration of response (DOR) and progression-free survival (PFS). Tumors were tested for ROS1 rearrangements by laboratory-developed break-apart fluorescence in situ hybridization (FISH) (96%) or real-time polymerase chain reaction (RT-PCR) (4%) assay.

The results of this study showed that Xalkori exhibited marked anti-tumor activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of ORR. Additionally, the safety profile of Xalkori in ROS1-positive advanced NSCLC was generally consistent with that observed in patients with ALK-positive advanced NSCLC.1 The updated data set used to support this approval will be presented at a future medical meeting.

Xalkori is widely recognized as a first-line standard of care for patients with ALK-positive advanced NSCLC. Xalkori was the first ALK inhibitor approved by regulatory authorities in the U., EU, China and Japan, and it is now approved in nearly 90 countries. To date, more than 25,000 patients have been treated with Xalkori worldwide.

ROS1 rearrangements occur when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. Epidemiology data suggest that ROS1 rearrangements occur in approximately one percent of NSCLC cases.3 Of the estimated 1.5 million new cases of NSCLC worldwide each year, roughly 15,000 may be driven by oncogenic ROS1 fusions.

Worldwide, lung cancer is the leading cause of cancer death in both men and women.6 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.7 Approximately 57 percent of NSCLC patients are diagnosed late with metastatic, or advanced, disease where the five-year survival rate is only 5 percent.