Pfizer has obtained breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Xalkori (crizotinib) to treat patients with ROS1-positive non-small cell lung cancer (NSCLC).
ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC, which is said to occur in 1% of NSCLC cases.
Pfizer oncology chief medical officer and clinical development and medical affairs senior vice-president Dr Mace Rothenberg said: "We are excited that the 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-tumour activity that can potentially make a real difference for patients."
The designation has been provided based on a data from an expansion cohort of a global Phase I trial, Study 1001, which assessed Xalkori in 50 patients with ROS1-positive advanced NSCLC.
According to the company, the study demonstrated that Xalkori exhibited marked anti-tumour activity in patients with ROS1-positive advanced NSCLC.
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Xalkori already received FDA approval to treat patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.
It obtained approval in around ten countries, including Australia, Canada, China, Japan, South Korea and the European Union.
Image: Pfizer world headquarters. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.