A new FDA approved way to try many drugs on many Cancers

Chemotherapy and radiation failed to thwart Erika Hurwitz’s rare cancer of white blood cells. So her doctors offered her another option, a drug for melanoma. The result was astonishing.

Within four weeks, a red rash covering her body, so painful she had required a narcotic patch and the painkiller OxyContin, had vanished. Her cancer was undetectable.“It has been a miracle drug,” said Mrs. Hurwitz, 78, of Westchester County. She is part of a new national effort to try to treat cancer based not on what organ it started in, but on what mutations drive its growth.

Cancers often tend to be fueled by changes in genes, or mutations, that make cells grow and spread to other parts of the body. There are now an increasing number of drugs that block mutations in cancer genes and can halt a tumor’s growth.

While such an approach has worked in a few isolated cases, those cases cannot reveal whether other patients with the same mutation would have a similar experience.

Now, medical facilities like Memorial Sloan Kettering Cancer Center in New York, where Mrs. Hurwitz is a patient, are starting coordinated efforts to find answers. And this spring, a federally funded national program will start to screen tumors in thousands of patients to see which might be attacked by any of at least a dozen new drugs. Those whose tumors have mutations that can be attacked will be given the drugs.The studies of this new method, called basket studies because they lump together different kinds of cancer, are revolutionary, much smaller than the usual studies, and without control groups of patients who for comparison’s sake receive standard treatment.

Researchers and drug companies asked the Food and Drug Administration for its opinion, realizing that if the F.D.A. did not accept the studies, no drugs would ever be approved on the basis of them. But the F.D.A. said it sanctioned them and could approve drugs with basket study data alone.

These are the sorts of studies many seriously ill patients have been craving, a guarantee that if they enter a study they will get a promising new drug.The studies move fast; it does not take years to see a big effect if there is one at all.