Xalkori (crizotinib) has been passed by the FDA as a treatment for patients suffering from ROS1-positive metastatic non-small cell lung cancer (NSCLC). The decision has been taken on the basis of the demonstration of substantial effectiveness in a phase 1 study.

It was based on data from 50 patients with ROS1-positive NSCLC wherein 66% was the overall response rate (ORR) with a median time period of response of 18.3 months by independent review.

Firstly a breakthrough therapy designation was given and then the approval arrived nearly 30 days ahead of a deadline decided under the Prescription Drug User Fee Act.

In a statement, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said that treatment of lung cancer isn’t easy, partially because patients possess distinct mutations, some of which aren’t common.

Pazdur added, “The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation by giving health care practitioners a more personalized way of targeting ROS-1 positive NSCLC”.

During the phase 1 trial, there were 50 patients with a median age of 53, who were given Xalkori at 250 mg twice every day in a nonstop 28-day cycle. Most of the patients had an ECOG performance status of 0 or 1 (98%), 78% of all patients had never been into smoking, and 98% had adenocarcinoma histology.

Among all the patients, 54% were white and 42% were Asian. Most of the patients, about 86%, have received treatment earlier, with 44% having received over one previous therapy. Overall, ROS1 was spotted in roughly 1% of screened patients with NSCLC.