5 March 2018 - A majority of oncology treatments granted accelerated approval over the last 25 years have gone on to demonstrate a clinical benefit, US FDA officials write in a review published in JAMA Oncology last week.

But the review notes that 5% of those drugs were eventually withdrawn from the market and that drugmakers have not yet completed post-marketing requirements (PMRs) for 40% of those indications.

Unlike regular approval, accelerated approval requires a drug to show an effect on a surrogate endpoint that is "reasonably likely to predict clinical benefit" for patients with a serious condition where there is an unmet medical need. When granting accelerated approval FDA will also require the sponsor to complete PMRs to confirm the product's benefit.

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