Pfizer Receives Breakthrough Therapy Designation for Xalkori

April 21, 2015
Pharmaceutical Technology Editors

FDA grants Pfizer Breakthrough Therapy designation for its treatment of ROS1-positive non-small cell lung cancer.

Pfizer announced on April 21, 2015 that it received FDA Breakthrough Therapy designation for Xalkori (crizotinib), a treatment for patients with ROS1-positive non-small cell lung cancer (NSCLC). Breakthrough Therapy designation is granted by FDA to expedite the development and review of a potential new medicine when preliminary clinical evidence suggests that it may be more effective than existing therapies in treating serious or life-threatening diseases.

“We are excited that FDA has granted Breakthrough Therapy designation for Xalkori as a potential treatment for patients with ROS1-positive NSCLC. 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,” said Mace Rothenberg, MD, senior vice-president of clinical development and medical affairs and chief medical officer for Pfizer Oncology, in a press release.

The designation was based on data from a global Phase I study that showed anti-tumor activity in 50 patients with ROS1-positive advanced NSCLC who received Xalkori. Xalkori is approved in the US for the treatment of patients with metastatic NSCLC with tumors that are anaplastic lymphoma kinase (ALK)-positive when detected by an FDA-approved test.

Source: Pfizer