Compliance Management / Large Molecule

Pfizer Lung Cancer Drug Gains FDA Priority Review

Dec 09, 2015

Pfizer Inc. announced that the U.S. FDA has granted Priority Review for a supplemental New Drug Application for XALKORI (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, XALKORI received Breakthrough Therapy designation by the FDA for this potential indication. If approved, XALKORI would be the first FDA-approved biomarker-driven therapy for the treatment of ROS1-positive metastatic NSCLC. According to Pfizer, XALKORI is currently indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The projected FDA action date is April 2016.

“ROS1 represents the second molecular subgroup of NSCLC in which XALKORI has demonstrated a level of anti-tumor activity that can potentially make a meaningful difference for patients,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “The development of XALKORI in this subgroup of patients is an example of the capability of precision medicine to identify treatments for patients whose tumors contain rare genetic mutations, such as ROS1-positive metastatic NSCLC.”

The submission to the FDA is based on data from a multicenter, single-arm Phase 1 study (Study 1001) that evaluated XALKORI in 53 patients with ROS1-positive metastatic NSCLC. Read the full release