The drug is already approved in Europe to treat adults with ALK-positive advanced NSCLC.
Earlier this year, the US Food and Drug Administration approved Xalkori for patients with metastatic NSCLC whose tumors are ROS1-positive.
The EC’s latest approval was backed by safety and efficacy data from a study of patients with ROS1-positive advanced NSCLC.
Results indicated that Xalkori achieved the primary endpoint of objective response rate, with Pfizer noting that the drug’s safety profile was generally consistent with the findings in patients with ALK-positive advanced NSCLC.
The company plans to present updated data from the study at an upcoming medical conference.
Pfizer Oncology regional president for international developed markets Andreas Penk said the commission’s decision to approve Xalkori for ROS1-positive advanced NSCLC represents an important milestone for patients who earlier had limited treatment options.
“We now know that NSCLC is not a single disease, but includes a number of molecularly defined tumors 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.”
Pfizer indicated that Xalkori is recognized widely as a first-line normal care for patients with ALK-positive advanced NSCLC. It has been approved in about 90 countries.
The company pointed out that over 25,000 patients across the world got the treatment with Xalkori.
Image: Pfizer World Headquarters New York City. Photo: courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany.