Pfizer: New cancer pill gives hope, new strategy

TRENTON, N.J. (AP) — Pfizer Inc.'s just-approved drug Xalkori, the first new medicine in more than six years for deadly lung cancer, proves the value of precisely targeting rare diseases linked to gene variants, cancer specialists and Pfizer executives said Tuesday.

The drug was approved Friday in the U.S. along with a companion diagnostic test for just a small subset of lung cancer patients. It epitomizes drugmakers' new strategy of developing very expensive but effective medicines for relatively few patients to replace the blockbusters for the masses now getting competition from generic drugs.

It's also in the vanguard of long-awaited personalized medicine, in which doctors identify patients with gene changes or variations that fuel their disease and then try to match them with new medicines that specifically target those genes.

"This is a paradigm shift," Dr. Paul A. Bunn Jr., a University of Colorado professor and cancer researcher involved in testing Xalkori, told journalists during a conference call hosted by Pfizer. "It used to be that everybody with cancer was treated the same," with surgery and chemotherapy.

Xalkori, a pill with relatively minor side effects compared to the hair loss and nausea that chemotherapy can cause, was approved for the roughly 4 percent of patients with advanced nonsmall cell lung cancer who have what's called the ALK fusion gene.

When ALK, short for anaplastic lymphoma kinase, and another gene on the same chromosome rearrange their positions and fuse together, the ALK gene stays on constantly, fueling cancer cell growth. Xalkori works by blocking the kinase enzyme, key to that process.

About 6,000 Americans a year develop this cancer, Pfizer said. Those patients, called ALK positive, now can be identified with a $250 molecular diagnostic test developed by Pfizer's partner, Abbott Molecular Oncology. The test was also approved Friday.

"You're going to be sparing individuals side effects (and) the waste of resources, time and drug that really isn't going to help them," Dr. Mark Kris, head of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York, said during the call.

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