PFIZER, DOCS: NEW CANCER PILL GIVES HOPE

Pfizer Inc.’s just-approved drug Xalkori, the first new medicine in six years for deadly lung cancer, proves the value of precisely targeting rare diseases linked to gene variants, cancer specialists and  Pfizer said.

The drug was approved recently in the U.S. along with a companion diagnostic  test for just a small subset of lung cancer patients. It epitomizes drug makers’ 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.

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

When ALK, short for anaplastic lymphoma kinase, and other gene on the chromosome rearrange their position 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, can now be identified with a $250 molecular diagnostic test developed by Pfizer’s partner, Abbott Molecular Oncology. The test was also approved recently.

Xalkori, known chemically as crizotinib, costs about $9,6000 a month and is taken till it stops fighting tumors at which point patients would likely be put on older chemo drugs that they hadn’t taken yet. Pfizer has started a Xalkori patient assistant program with a maximum $100 monthly copayment for insured patients meeting certain financial limits. Insurers are expected to cover the drug for ALK positive patients.