Mood music changes as FDA gets tough on early I-O nods

After two days of discussions yielding  reaffirmed support for Tecentriq’s (atezolizumab) Accelerated Approvals, the US regulator’s scientific panel changed tack on Thursday, voting to rescind decisions for both Keytruda (pembrolizumab) and Opdivo (nivolumab).

The three-day series of meetings was called as part of a wider review of Food and Drug Administration nods made under the Accelerated Approval program, where confirmatory data has not been supplied.

While the FDA is not bound by the advisory panel, it tends to follow the decisions reached during such discussions.