ARTICLE | Regulation

ASCO’s bright line

Why patients, docs say ASCO’s approval standards would reduce treatment options

August 19, 2017 2:48 AM UTC

A policy recommendation by the American Society of Clinical Oncology to raise the bar on cancer drug approvals as a means to combat high drug prices ignores the historical fact that big survival gains have been knitted together from incremental gains, and could lead to fewer therapeutic options, according to patient and physician groups who spoke to BioCentury.

In a July 19 position statement on affordability in cancer care, ASCO recommended that FDA approve drugs only if they produce “clinically meaningful” benefits as defined by tumor experts, “rather than focusing on small benefits that achieve statistical significance in trials.” ...