Pfizer receives FDA Breakthrough Therapy Designation for XALKORI to treat ROS1-positive NSCLC

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WASHINGTON - April 21, 2015 - PRLog -- Pfizer has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for  XALKORI® (crizotinib) to potentially treat patients with ROS1-positive non-small cell lung cancer (NSCLC). ROS1-positive NSCLC patients represent one percent of all NSCLC cases and XALKORI is already approved in the U.S to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

“We are excited that the FDA has granted Breakthrough Therapy designation for XALKORI as a potential treatment for patients with ROS1-positive NSCLC,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “XALKORI pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which XALKORI has demonstrated a level of anti-tumor activity that can potentially make a real difference for patients.”

Established in 2012, the Breakthrough Therapy Designation is intended to accelerate the research and development process for drugs designed to treat serious or life threatening conditions. This designation was awarded to Pfizer based on the global Phase 1 study (Study 1001). According to data published in the New England Journal of Medicine, XALKORI produced effective anti-tumor activity in patients with ROS1-positive advanced NSCLC. The safety profile was also similar to that observed in patients with ALK-positive advanced NSCLC.

Pfizer intends to work meticulously with the FDA on the development of XALKORI for ROS1-positive NSCLC with the aim of providing the necessary information to support a potential regulatory submission.

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