Pfizer nabs EU approval for Xalkori for certain lung cancers
pharmafile | August 31, 2016 | News story | Sales and Marketing | Pfizer, Xalkori, lung cancer, non-small cell lung cancer
The European Commission has approved Pfizer’s Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC).
The drug, which is also approved in the EU for adults with ALK-positive forms of advanced non-small cell lung cancer, has already been approved in the ROS1 indication by the US FDA.
It is believed that rearrangements in the ROS1 gene, when it attaches to another gene and changes its normal function, are accountable for around 1% of non-small cell lung cancer cases. With this latest approval, Pfizer calls Xalkori the only biomarker-driven therapy approved for patients with either ALK positive or ROS1-positive advanced non-small cell lung cancer in the EU and US.
This approval is partially based on Phase I data which showed a 66% overall response rate, with a median duration of response of 18.3 months.
Andreas Penk, regional president of international developed markets at Pfizer Oncology, says: “The European Commission’s decision to approve Xalkori for ROS1-positive advanced NSCLC represents an important milestone for patients who previously had limited treatment options. We now know that NSCLC is not a single disease, but includes a number of molecularly defined tumours with different clinical characteristics and treatment options.
“With EU approvals in two distinct molecular targets in advanced NSCLC, ROS1 and ALK, Xalkori continues to break new ground and exemplify our commitment to precision drug development and patients.”
Sean Murray
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