Pfizer Receives Breakthrough Therapy Designation for Xalkori
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
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
