FDA approved Nexavar, a drug that officials described as “a major advance” in treating kidney cancer.
The manufacturer of Nexavar, Bayer, used X-rays to determine that the drug doubled the time, to 167 days from 84, before tumors grew substantially in number or size, a finding called “progression-free survival.”
Officials of the drug agency found the findings so compelling that they urged Bayer to stop the trial early and give Nexavar to subjects who had been taking placebos.
European regulators, on the other hand, wanted the trial to continue because they wanted Bayer to prove that Nexavar actually extended lives, a finding that would have taken many more months to establish, a deputy commissioner of the drug agency, Dr. Scott Gottlieb, said Tuesday in an interview.
“Nexavar is a good example of how we have developed better science around the development process itself that not only enables these drugs to come to market but to come to market more quickly,” Dr. Gottlieb said.
There have been successes in oncology besides Nexavar, of course. Platinum-based drugs have mostly ended deaths from testicular cancer. Tamoxifen and Herceptin have saved thousands of women from breast cancer. And early screening has helped push down death rates.
Researchers are not alone in their failures. Drug makers are in the midst of a dry spell that threatens the foundations of the industry. After peaking in 1996 at 53, the number of new drug approvals has steadily declined. This year, it is unlikely to exceed 17.
Although every field has suffered, cancer has had the greatest chasm between hope and reality. One in 20 prospective cancer cures used in human tests reaches the market, the worst record of any medical category. Among those that gained approval in the last 20 years, fewer than one in five have been shown to extend lives, life extensions usually measured in weeks or months, not years.
Drug companies have been promising for years that gene-hunting techniques would yield targeted nontoxic therapies that melt cancer, but few cancer medicines fit that profile.
Nexavar, for instance, seems to affect a variety of crucial molecules involved in powering cancer cells, but its real effects are uncertain. It can cause rashes, diarrhea and increases in blood pressure, although drug agency officials said it was far less toxic than previous therapies.
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Source: New York Times