MedCity News April 20, 2023
Over the past 2 years, concerted efforts have been undertaken by policymakers and FDA’s Oncology Center of Excellence to mitigate risks and improve the transparency of the accelerated approval program. These actions are crucial to restoring public trust – trust that has suffered considerable erosion.
The accelerated approval pathway was established in 1992 to expedite access to new therapies for patients with serious or life-threatening diseases. First created as a strategy to rapidly address unmet medical need during the HIV-AIDS crisis, oncology drugs now comprise the largest proportion of accelerated approvals. Use of this pathway allows the FDA to grant approval sooner based on surrogate endpoints that are reasonably likely to predict clinical benefit. But the caveat is that the...
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