FDA Awards Breakthrough Status to BMS and Merck Lung-Cancer ADCs

The U.S. Food and Drug Administration has issued two Breakthrough Therapy Designations for investigational antibody-drug conjugates aimed at hard-to-treat forms of lung cancer. Bristol Myers Squibb and partner SystImmune secured the status for izalontamab brengitecan, a bispecific EGFR- and HER3-targeting ADC, in adults with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 19 deletions or exon 21 L858R mutations whose disease progressed after an EGFR tyrosine-kinase inhibitor and platinum-based chemotherapy. Separately, Merck and Daiichi Sankyo received the same regulatory incentive for ifinatamab deruxtecan, a B7-H3-directed ADC, in adults with extensive-stage small cell lung cancer that has advanced following platinum-based therapy. Breakthrough status is intended to accelerate development and review of medicines that may offer substantial improvements over existing options, giving both programs access to closer FDA guidance and the possibility of expedited approval paths.