RE:RE:RE:RE:RE:Phase 1/2 AMBUSH Trial Despite the trial flop, there may be hope for the GSK drug. The FDA has previously allowed cancer accelerated approvals to remain on the market despite a confirmatory fail, especially when another study that could serve as the new confirmatory trial nears a readout. Given the imminent readout from the other two DREAMM studies, the FDA likely won’t act on Blenrep now.
But the FDA’s decision to keep an accelerated approval intact also depends on whether unmet medical need still exists in the drug’s approved use. There, Blenrep’s argument is relatively weak.