publication date: Jul. 10, 2015
Do-It-Yourself Guide to ODAC
Circle One: Yes, No, Maybe
FDA has often asked ODAC members to discuss broad scientific questions. However, the approval questions have, without an exception, been shoehorned into the up-or-down dichotomy.
What is ODAC without a vote on approval questions?
Here, The Cancer Letter has combined a transcript of the ODAC discussion with a coding scale that may provide a clue about how the vote on necitumumab would have gone.
Grzegorz Nowakowski, assistant professor of medicine, Mayo Clinic Rochester:
I think this is a well-conducted study, which provides a small but significant benefit in terms of overall survival, which is the endpoint, which captures both safety and efficacy of this combination. The toxicity is acceptable, considering the severity of the disease.
I think there are concerns about the supportive care, which we alluded to, about replacement of magnesium, and thromboembolism prophylaxis, but overall I believe that the risk-benefit ratio appears to be pointing towards the benefit of this combination.
Code this answer (circle one): Yes No Maybe
Michael Menefee, assistant professor, Division of Hematology and … Continue reading 41-27 Do-It-Yourself Guide to ODAC Circle One: Yes, No, Maybe
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