FDA approves Pfizer sNDA for Xalkori
pharmafile | March 14, 2016 | News story | Research and Development, Sales and Marketing | Cancer, EMA, NSCLC, Pfizer, Xalkori (crizotinib)
The US FDA has approved Pfizer’s supplemental new drug application (sNDA) for its kinase inhibitor Xalkori in treating patients with metastatic Non-Small Cell Lung Cancer (mNSCLC), whose tumours test positive for ROS1.
The news follows the Agency’s approval for the drug in anaplastic lymphoma kinase (ALK)-positive mNSCLC last year, and it granting Xalkori (crizotinib) Breakthrough Therapy and Priority Review designations in ROS1-positive metastatic NSCLC. Xalkori was also approved in Europe for ALK-positive mNSCLC last December.
The latest approval was based on a Phase I study in which 50 patients with ROS1-positive mNSCLC were treated with Xalkori. The drug initiated marked anti-tumour activity, with 66% of patients responding, and the median duration of response was 18.3 months. The trial saw one complete response and 32 partial responses.
“(The) approval of Xalkori for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options,” said Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “As the only FDA-approved biomarker-driven therapy that includes two distinct molecular targets in metastatic NSCLC, ROS1 and ALK, Xalkori exemplifies our commitment to precision drug development and to identifying the right treatment for the right patient.”
ROS1 rearrangements occur when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. It is believed that around 1% of NSCLC cases are ROS1 positive. While the FDA has not yet approved a diagnostic test for the detection of ROS1-positive patients, laboratory-developed tests are available.
EMA is also currently reviewing an application for Xalkori in ROS1-positive advanced NSCLC.
Joel Levy
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