FDA Issues Complete Response Letter for Summit’s Ivonescimab BLA in EGFR-Mutant NSCLC

A complete response letter is a regulatory setback, not a rejection, and the disclosed sticking point — overall survival as a key endpoint — signals the FDA wants the hardest evidence before clearing a drug in a previously treated EGFR-mutant population where existing TKIs set the bar. The read-across matters for the broader class of bispecific antibody-chemotherapy combinations chasing accelerated pathways, since a CRL on endpoint design can reset timelines across similar filings. Whether Summit's next step is a new trial or further dialogue with the agency is the open question, and how the FDA frames survival requirements here will be watched by other developers in the same space.