FDA approves cancer drugs without proof they’re extending lives | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For decades, researchers have focused ondeveloping new cancer drugs that save lives or improve the quality of life. But when the U.S. Food and Drug Administration allowed Inlyta, a $10,000 a month drug, on the market in 2012, there was no proof that it did either.


Inlyta is not an exception to the rule.


A Milwaukee Journal Sentinel/MedPage Today analysis of 54 new cancer drugs found that over the last decade the FDA allowed 74% of them on the market without proof that they extended life. Seldom was there proof of improved quality of life, either.


Nor has the FDA demanded companies provide such evidence.

Instead, the agency approved the drugs based on surrogate measures, such as a tumor shrinking, rather than the gold standard and most reliable measure of cancer research, patients actually surviving longer. The problem is cancer is complicated — a tumor might stop growing or shrink in one spot, then reappear somewhere else, or even in multiple places.


Inlyta, manufactured by Pfizer, was allowed on the market based on a commonly used surrogate known as progression-free survival, which means patients survived longer before doctors detected a tumor worsening.


Patients given Inlyta saw no noticeable progression of their disease for an average of 6.7 months, two months longer than those who got a control drug. But patients who got Inlyta did not live any longer.

Before Inlyta was approved, an FDA reviewer noted it would be the seventh drug for advanced kidney cancer approved by the FDA since 2005. Only one of them, a drug known as Torisel, had actually proven to help people live longer.


Prompted by politicians, pharmaceutical companies and advocacy groups seeking to speed up drug approvals, the FDA has allowed shortcuts to make it easier for companies to get products on the market.


A big part of that has been the use of surrogate measures.


For instance, diabetes drugs usually are approved based on lowering blood-sugar levels, rather than clinical benefits such as fewer amputations and heart attacks.


Heart drugs may be approved based on tests measuring various fats in the blood rather than fewer heart attacks, strokes or cardiovascular deaths.


Surrogate measures, which allow for shorter, smaller and cheaper clinical trials, have opened the gates to a steady stream of costly drugs of dubious value.


"The whole paradigm is broken, and it is an unmitigated disaster," said Peter F. Thall, a biostatistician at MD Anderson Cancer Center in Houston who designs clinical trials for cancer research.