’Selective approval’ would require follow up studies to identify most appropriate patients
One of the most promising new strategies for cancer treatment is the development of drugs that directly target molecular abnormalities that lead to the growth of tumors. Several such drugs have received Food and Drug Administration (FDA) approval in recent years, but some have been controversial because the data on which they were approved did not clearly define which patients will most benefit from the new medications.
Writing in the July 29 New England Journal of Medicine, two specialists from the Massachusetts General Hospital (MGH) Cancer Center propose an expansion of the FDA’s "fast-track" programs for drug approval. In their "Sounding Board" piece, Thomas Roberts Jr., MD, and Bruce Chabner, MD, call on the FDA to require pharmaceutical companies to carry out studies identifying the patients most likely to respond to a targeted-therapy drug, as a condition of the drug’s approval.
Sue McGreevey | EurekAlert!
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