Experts debate FDA signals on cancer drug approval

When is a cancer therapy good enough? The Boston Globe examines answers to that question following the recent controversy over the FDA's decisions in the field. Most recently, Avastin gained a new approval after it demonstrated an ability to delay the development of breast cancer tumors. But researchers never demonstrated an improvement in symptoms or the drug's ability to extend patients' lives.

"If the goal of any new therapy is to cure metastatic breast cancer, it is going to be a very long time--if ever--before we see it," Dr. Maurie Markman, vice president for clinical research at M.D. Anderson Cancer Center in Houston, tells the Globe.

But where's the real benefit for patients? A number of experts say that research should set out to prove if a therapy actually improves their quality of life. But others are quick to add that that can be a very ambiguous standard.

- read the report [1] in The Boston Globe

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