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April 22, 2015

Pfizer’s Xalkori gets FDA breakthrough therapy designation for ROS1-positive NSCLC

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).

Pfizer

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 has demonstrated a level of anti-tumour activity that can potentially make a real difference for patients."

"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.

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.

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