FDA Okays Pfizer's Lung Cancer Drug Xalkori For Expanded Use


Federal authorities on Friday granted the expanded use of Pfizer's Xalkori (crizotinib) to treat patients with advanced non-small cell lung cancer.

The Pfizer drug will be allotted for the 1 percent of lung cancer patients with a rare mutation, or whose tumors have an ROS-1 gene alteration, which is believed to lead to abnormal cells, the Food and Drug Administration said.

Xalkori is the first and only FDA-approved therapy for the condition. A companion diagnostic test is currently being developed to help identify patients with ROS-1 mutated lung cancer.

First authorized in 2011, Xalkori is said to be effective in decreasing the size of tumors in ROS-1 mutated lung cancer patients. A clinical trial in 2014 revealed that the drug had a 72 percent success rate, reducing the size of tumors in 36 out of 50 patients.

FDA's Dr. Richard Pazdur said lung cancer is difficult to treat, partly because patients have different mutations. Some mutations are quite rare.

"The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult-to-treat ROS-1 gene mutation," said Pazdur.

Dr. Alice Shaw of Massachusetts General Hospital, said the approval of Xalkori represents another significant step forward in biomarker-driven cancer care.

Meanwhile, a Pfizer spokesperson said Xalkori's price list is $14,336 a month. This is before any rebates or discounts are given by manufacturers to insurers and other payers.

The European Medicines Agency is also examining an application to extend the marketing of the therapy to adult patients with the rare lung cancer mutation.

There are about 1.5 million new cases of non-small cell lung cancer around the world every year. Out of it, 15,000 are affected by ROS-1 gene alterations. Reports suggest that the mutation is often found in younger patients who are non-smokers.

In the United States, lung cancer is the leading cause of cancer-related deaths. According to the National Cancer Institute, there were 221,000 new diagnoses and 158,040 deaths due to lung cancer in 2015.

Pfizer cautioned that women are not advised to breast feed babies during treatment with Xalkori. It is also dangerous to pregnant women. Patients are also advised to avoid eating grapefruit or drinking grapefruit juice while on treatment because it may increase plasma concentrations of crizotinib.

Photo: Aidan Jones | Flickr

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