FDA expands use of Pfizer drug for rare form of lung cancer

The Food and Drug Administration expanded approval of a Pfizer drug to treat a small subset of lung cancer patients with a rare mutation.
The agency said today that Xalkori capsules are now approved for patients with the ROS-1 gene mutation, who make up about 1 percent of US patients with non-small cell lung cancer, the most common form of the disease.
The twice-a-day drug is part of a new generation of medications that fight disease by targeting specific genes found in certain patients. It was initially approved in 2011 for another subset of lung cancer patients who have an abnormal gene that stimulates tumor growth.

The drug blocks certain proteins found in tumors with genetic mutations, with the aim of slowing the spread of cancer.
"Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare," said Dr Richard Pazdur, FDA's director for cancer drugs, in a statement. "The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation."
Like most new cancer drugs, Xalkori carries a hefty price tag: USD 14,336 per month, or about USD 172,000 per year. That number does not take into account discounts and rebates often negotiated by insurers. Pfizer posted sales for the drug of USD 438 million in 2014, according its most recent annual report.

The FDA approved the new indication based on a study in 50 patients in which 66 percent of patients saw their tumor shrink partially or completely. That benefit lasted about 18 months for the typical patient.

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"We are committed to creating an affordable and
sustainable programme supporting administration of our pneumococcal conjugate vaccine, which has the broadest stereotype coverage of any pneumococcal conjugate vaccine available in the world today," the spokesperson said.
Working with GAVI, the vaccines alliance, Pfizer has already committed to supply up to 740 million doses of its pneumococcal vaccine to help prevent 7 million childhood deaths by 2030, the spokesperson said.

"Since 2010, more than 40 low-and lower middle-income countries have launched pneumococcal immunisation programmes with Prevenar 13, via Gavi's innovative Advance Market Commitment program and as of this month we have shipped more than 200M doses toward that goal," the spokesperson added.