Meet Pfizer’s Newest FDA Designations

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Pfizer Inc. (NYSE: PFE) announced early on Monday that it received a couple critical updates from the U.S. Food and Drug Administration (FDA). The agency granted a Breakthrough Therapy designation for Pfizer’s Xalkori (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy.

The FDA also granted Breakthrough Therapy designation for Xalkori for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive.

Currently, Xalkori is approved in the United States for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test. Xalkori became a first-line standard of care for ALK-positive metastatic NSCLC in its first approved indication and has proven to be a practice-changing treatment for patients with ALK-positive and ROS1-positive NSCLC globally.

Note that Xalkori is the only FDA-approved treatment indicated for both ALK-positive and ROS1-positive metastatic NSCLC. If approved in patients with metastatic NSCLC with MET exon 14 alterations, Xalkori will be the only tyrosine kinase inhibitor with demonstrated efficacy in three separate biomarker-driven indications in NSCLC.

Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development, commented:

Biomarker-driven therapies have changed the way we treat cancer, helping to ensure that patients receive the right medicine for their disease. These Breakthrough Therapy designations for XALKORI exemplify our commitment to precision medicine development and delivering medicines that have the potential to transform the lives of patients whose cancers carry these genomic alterations.

Shares of Pfizer closed Friday at $35.68, with a consensus analyst price target of $39.60 and a 52-week range of $31.67 to $39.43.