Pfizer’s XALKORI® (Crizotinib) Receives Approval for the Treatment of Patients with ROS1-Positive Advanced Non-Small Cell Lung Cancer in European Union

Pfizer Igea Luca Dezzani

Pfizer Igea Luca Dezzani

August 31, 2016

Pfizer Inc. has announced that it has got approval from the European Commission for XALKORI® (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). XALKORI is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC in the European Union (EU). In March of this year, United States (U.S.) Food and Drug Administration approved XALKORI for patients with metastatic NSCLC whose tumors are ROS1-positive. XALKORI becomes the only biomarker-driven therapy approved for patients with either ROS1-positive or ALK positive advanced NSCLC in the U.S. and EU.

Andreas Penk, MD, Regional President, International Developed Markets, Pfizer Oncology, said: “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. 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.”

According to the results of this study, XALKORI exhibited marked anti-tumor activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of objective response rate (ORR). Furthermore, the safety profile of XALKORI in ROS1-positive advanced NSCLC was mostly consistent with that observed in patients with ALK-positive advanced NSCLC.

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