Breakthrough Therapy designation for Pfizer’ Xalkori in NSCLC type

US pharma giant Pfizer (NYSE: PFE) says that its Xalkori (crizotinib) has received Breakthrough Therapy designation from the US Food and Drug Administration for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).

Occurring in around 1% of NSCLC cases, ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC. Xalkori currently is approved in the US for the treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Xalkori's sales are currently about $350 million a year, but Cowen and Co analysts estimate the drug's annual sales will peak at $1 billion by 2020, according to Reuters.