The US Food and Drug Administration (FDA) has accepted and granted priority review for Pfizer’s supplemental new drug application (sNDA) for Xalkori (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive.
For this potential indication, Xalkori has also received breakthrough therapy status from the FDA in April.
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If approved, Xalkori would be the first FDA-approved biomarker-driven therapy to treat ROS1-positive metastatic NSCLC.
ROS1 rearrangement occurs when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can lead to growth of cancer-cell.
According to epidemiology data, ROS1 rearrangements occur in around 1% of NSCLC cases.
Currently, the drug is indicated for patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.
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By GlobalDataPfizer Oncology Clinical Development and Medical Affairs senior vice-president and chief medical officer Dr Mace Rothenberg said: “ROS1 represents the second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumour activity that can potentially make a meaningful difference for patients.
“The development of Xalkori in this subgroup of patients is an example of the capability of precision medicine to identify treatments for patients whose tumours contain rare genetic mutations, such as ROS1-positive metastatic NSCLC.”
The sNDA was based on data from a multicentre, single-arm Phase I trial (Study 1001) that evaluated Xalkori in 53 patients with ROS1-positive metastatic NSCLC.
Data from 50 of these patients showed that Xalkori exhibited marked anti-tumour activity in patients with ROS1-positive metastatic NSCLC.
In addition, the safety profile of Xalkori in ROS1-positive metastatic NSCLC was consistent with that observed in patients with ALK-positive metastatic NSCLC.
So far, Xalkori has been approved in more than 85 countries, including Australia, Canada, China, Japan, South Korea and the European Union (EU).
Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.
