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FDA Breakthrough Therapy: Pfizer’s Xalkori For ROS1+ NSCLC

April 21, 2015

Pfizer announces April 21st, that the FDA grants the Breakthrough Therapy Designation (BTD) to Xalkori (Crizotinib). The BTD is for ROS1-positive (ROS1+) Non-Small Cell Lung Cancer (NSCLC). ROS1+ NSCLC is a subgroup of NSCLC, occurring in about 1% of NSCLC cases. Currently, Xalkori is FDA approved for metastatic NSCLC, where tumors are Anaplastic Lymphoma Kinase positive (ALK+) as determined by a FDA-approved test. Xalkori has received approval in more than 80 countries.

According to the Pfizer Press Release, Dr. Mace Rothenbery, 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.”

This is the 3rd BTD Pfizer has received, with the FDA approval of 2 of the BTDs:

•   Ibrance (Palbociclib) for breast cancer in April 2013 with FDA approval in February 2015

•   Trumenba (Bivalent rLP2086 Vaccine) for Meningococcal B Disease with FDA approval in October 2014

•   Xalkori (Crizotinib) for Ros1+ NSCLC.



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “White Pocket Reflection” by John Fowler (Flickr: White Pocket Reflection) [CC BY 2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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