In the face of evidence that thousands of patients become so ill that they skip doses or stop taking the drugs thereby risking resurgence of their cancers the FDA has begun requiring companies to pinpoint the right dosage before they reach patients.
At the time, the FDA's leading cancer drug regulator, Richard Pazdur, co-authored an editorial in the New England Journal of Medicine that said Amgen's trials of the $20,000-a-month drug were hampered by a lack of robust dose exploration.
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