Posted by Michael Wonder on 16 May 2018
Evolving landscape of US FDA drug approval in the era of precision oncology: finding the right balance between access and safety
15 May 2018 - Since 1992, the US FDA has implemented several programs for streamlined review and approval of agents that treat serious or life-threatening conditions, including the accelerated approval pathway as well as designations for priority review, fast-track, and breakthrough therapies.
Accelerated approval is based on surrogate endpoints considered to have a reasonable likelihood of leading to overall clinical benefit, and it is conditional on confirmatory post-approval trials. The trial end points used to determine long-term clinical benefit depend on the specific disease setting and on the availability of effective alternative treatments.
Despite limited evidence of clinical benefit and safety, agents that receive accelerated approval enter the market as FDA-approved products available for clinical use, contingent on provider, patient, and payer concurrence.
