Lung Cancer Drug Gains Approval in the European Union

Xalkori received approval for ROS1-positive advanced non-small cell lung cancer.

Pfizer announced that Xalkori (crizotinib) received European Commission approval for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).

It is also indicated in the European Union for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer. Xalkori received FDA-approval for the treatment of patients with metastatic non-small cell lung cancer whose tumors are ROS1-positive in March, according to Pfizer.

The drug is now the only biomarker-driven therapy for patients with anaplastic lymphoma kinase-positive or ROS1-positive advanced non-small cell lung cancer in the European Union and the United States.

The most recent approval is based on the positive opinion from the European Medicine’s Agency that is supported by results from a phase 1 study. The phase 1 trial, Study 1001, included patients with ROS1-positive advanced non-small cell lung cancer treated with 250 milligrams of Xalkori twice per day.

Researchers evaluated the efficacy through objective response rate determined by RECIST (Response Evaluation Criteria In Solid Tumors). Secondary endpoints were time to tumor response, duration of response, and progression-free survival.

ROS1 rearrangements were determined through laboratory-developed break-apart glouresence in situ hybridization (96%), or real-time polymerase chain reaction (4%) assay, according to Pfizer. ROS1 rearrangements happen when the ROS1 gene attaches to another gene and alters gene functions in a way to promotes cancer cell growth.

Xalkori showed significant anti-tumor activity and met its primary endpoint of objective response rate. Researchers also found a similar safety profile in these patients, compared with individuals who had ALK-positive non-small cell lung cancer.

Known adverse effects include hepatotoxicity, interstitial lung disease, QT interval prolongation, bradycardia, vision loss or disorders, and embryo-fetal toxicity. Xalkori has been approved in nearly 90 countries, and have treated more than 25,000 patients, according to Pfizer.

“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,” said Andreas Penk, MD, regional president, International Developed Markets, Pfizer Oncology. “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 2 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.”