A meeting of the FDA’s Oncologic Drugs Advisory Committee earlier this month discussed the use of retrospective biomarker data in making regulatory decisions. Amgen and ImClone are seeking approval to include such data on drug labels. Amgen’s Vectibix and ImClone’s Erbitux are monoclonal antibodies used to treat colon cancer. Amgen is also seeking approval of a diagnostic test to accompany Vectibix. Both companies have submitted biomarker data that show that patients with KRAS gene mutations do not respond to the drugs. The data was collected retroactively from clinical trials that were not initially designed to test such biomarkers. Richard Pazdur, director of the FDA’s Office of Oncology Drug Products, noted that retrospective biomarker studies can result in false findings, but also that new data can lead to discoveries about the genetic effectiveness of a drug after its approval. He stated that ideally a drug and its biomarker should be developed at the same time so that a clinical trial can be designed to test the effectiveness of both.

Source: BioWorld Online

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