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 now are 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 the same experience.
Now, medical facilities such as Memorial Sloan Kettering Cancer Center in New York, are starting coordinated efforts to get some answers. 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. The studies of this new method, called basket studies because they lump together different kinds
of cancer, are revolutionary, 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 FDA did not accept the studies, no drugs would ever be approved on the basis of them.
But the FDA said it sanctioned them and could approve drugs with basket-study data alone.
These are the sorts of studies that many seriously ill patients have been craving, a guarantee
that if they enter a study they will get a promising new drug. Also the studies move fast; it does
not take years to see a big effect if there is one at all.
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