Lessons From Avastin: Accelerated Approval Needs “Easy On, Easy Off” Mechanism, Pazdur Says
FDA’s oncology office director says the resource-intensive hearing process for withdrawing bevacizumab’s breast cancer claim demonstrates that it is “untenable for a large number of drugs.”
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Applying the expedited pathway in the context of a preliminary benefit/risk assessment, rather than focusing solely on predictive surrogate or intermediate clinical endpoints, would give the US FDA more flexibility, Friends of Cancer Research working group says in a new white paper.
While not identifying specific situations raising potential questions, the FDA commissioner uses his appearance at agency's annual rare disease event to advise regulatory decisions may be revisited as more data becomes available.
Lilly withdraws soft tissue sarcoma drug for failure to confirm clinical benefit two and a half years after US FDA awarded accelerated approval, becoming the fastest withdrawal yet under the regulatory pathway.