What are Merck, Bristol Myers and Roche planning for the big FDA cancer approval review?

In a three-day meeting starting Tuesday, a panel of external experts convened by the FDA will discuss whether the agency should consider clawing back accelerated approvals from three immuno-oncology agents.

All six conditional nods, shared among Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo and Roche’s Tecentriq, were based on early data showing they could shrink tumors or slow disease progression. But the companies have since failed to show the treatments could help patients live longer in confirmatory trials. Industry watchers have been closely following the event to gauge the FDA’s standard and level of leniency on go-aheads based on surrogate trial markers that didn’t translate into a survival benefit.