Pfizer’s XALKORI® (crizotinib) Receives FDA Breakthrough Therapy Designation in Two New Indications

Pfizer (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for 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 (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.

As quoted in the press release:

MET is a transmembrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors.¹ Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease.^2,3 Despite the activity of chemotherapy, many patients with ALCL relapse or require alternative treatment approaches.⁴

“Biomarker-driven therapies have changed the way we treat cancer, helping to ensure that patients receive the right medicine for their disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “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.”

Click here to read the full press release.