Pfizer announced that the Food and Drug Administration has approved Xalkori, generically known as crizotinib, a new medicine that can have a dramatic impact in a small minority of lung cancer patients.
The drug will come with a high financial cost to society. Pfizer says it will cost $9,600 a month, or $115,000 for patients who take it for a year. In clinical trials, the average duration of treatment was between 22 and 32 weeks, but because the drug appears to extend patients lives, many may be on it for far longer than that. One study, presented at this year's American Society of Clinical Oncology meeting, said that 60% of patients on Xalkori were alive after two years, compared to 9% in historical controls. (See: Pfizer Drug Powers Cancer Into The DNA Age.)
However, Pfizer is making efforts to make sure that patients themselves don't have to pay the cost. It says that it will cover insurance copayments that are more than $100, and that it will give the drug away free to eligible patients who are either uninsured or under-insured.
Only 5% of patients with non-small cell lung cancer have the mutation in the ALK gene that Xalkori targets, but lung cancer is so common that this still represents some 9,000 people each year. In one study of 136 patients, half of patients responded to the drug, based on scans of their tumors.In a second study, 61% of patients responded. Three patients saw their tumors disappear from the scans.
The studies did not have a control group, and Pfizer will have to conduct larger clinical trials comparing Xalkori to existing chemotherapies as a condition of approval.
Xalkori is the second cancer drug approved this year to give a real benefit to patients with a specific mutation. The first was Zelboraf, from Daiichi Sankyo's Plexxikon unit and Roche, which costs about $60,000 per patient. Together they represent new hope for patients but also problems of cost that will affect drug companies, insurers, and the government. (See: Cancer's New Era Of Promise And Chaos).
A new age of medicines will work very well in a select few. But many disease sufferers may need several new drugs at once to have an effect–and, unlike older combination drugs, some of these medicines may work only as combinations, not by themselves. That scares the FDA and drug companies both. But pharmaceutical firms have shown new willingness to develop drugs for very rare diseases partly because they have found they can charge a small fortune for the ones that work.
For Pfizer, this is decidedly good news. As Timothy Anderson, the pharmaceuticals analyst at Sanford C. Bernstein writes, between now and the end of next year Pfizer is likely to introduce five "meaningful" drugs and vaccines. Four of these, Anderson writes in a note to investors, shoudl be able to generate $1 billion in annual sales or more. "For a company that many, including ourselves, have viewed as the poster-child for inefficient R&D spending, this is a remarkable achievement assuming all goes as planned," Anderson writes.
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