{{In 2006 when doctors started testing a melanoma treatment made by Roche Holding AG on patients, they were used to facing slim odds – about one in eight – that the tumors would shrink on chemotherapy. This time, they couldn’t believe their eyes.}}<\/p>\n
With Zelboraf, a drug that targets specific mutations in cancer cells, eight out of 10 patients in an early-stage trial experienced significant tumor shrinkage. Roche clearly had a remarkable drug, though it only worked for people with a specific genetic makeup.<\/p>\n
Research like the Zelboraf tests, that fine-tune treatments to the genetic profile of patients, is fueling a rethink over how new cancer drugs are tested. The promise: medicines that, in theory at least, can win approval more easily and cheaply.<\/p>\n
That also raises ethical questions. If you know a certain treatment is genetically bound to work much better on some people than on others, is it right to conduct randomized trials to see which works best? <\/p>\n
Zelboraf led some doctors to question whether to go ahead with the trials they had planned, trials that would pit Zelboraf against the standard treatment, a chemotherapy developed in 1975 called dacarbazine.<\/p>\n
Some doctors believed that would risk patients’ lives unnecessarily. U.S. Food and Drug Administration cancer drug czar Dr. Richard Pazdur pushed for changes to shorten the trial. <\/p>\n
Others, such as Dr. Patrick Hwu of MD Anderson Cancer Center in Texas, refused to participate in a study that seemed bound to disadvantage some patients.<\/p>\n
Ultimately, the trial proceeded and the drug won U.S. approval in 2011. But experts say the controversy over Zelboraf broke the mould, potentially pointing the way to lower-cost drug development.<\/p>\n
At least one company has already indicated it will cut prices. Earlier this year, GlaxoSmithKline Plc won approval from the U.S. Food and Drug Administration for Tafinlar, a drug targeting the same mutant genes as Zelboraf, based on a single clinical trial of just 250 patients. It said the drug would cost $7,600 a month, 30 percent less than Zelboraf.<\/p>\n
Whether others follow suit in cutting prices will depend on a host of issues, perhaps the biggest of which is the vast difference in the way the United States and Europe regulate drugs.<\/p>\n
Pressure is mounting. A new and highly promising class of immunotherapy drugs – which some analysts see as a potential $35 billion a year market – may force companies’ hands. <\/p>\n
These therapies will come to market just as more people are asking if health insurers and governments will keep paying sky-high prices.<\/p>\n
Dr. Alexander Eggermont, chief executive of Institut Gustave-Roussy, France’s largest cancer center, was one of those who held a hard line on Zelboraf testing, insisting on a randomized trial. <\/p>\n
But Eggermont now says the standard of proof has changed and he believes immunotherapies – which he calls the “biggest game changer we have ever seen” – will cement the new approach to testing.<\/p>\n
“We won’t have to do those dinosaur trials,” he said. “It will change the whole attitude in drug development.”<\/p>\n
{reuters}<\/p>\n","protected":false},"excerpt":{"rendered":"
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