Merck and Daiichi withdraw lung cancer ADC filing after FDA says data insufficient
Merck and Daiichi Sankyo have pulled their application for accelerated approval of a B7-H3-directed antibody-drug conjugate aimed at extensive-stage small cell lung cancer.
The FDA indicated that the data from the phase 2 IDeate-Lung01 trial, which enrolled 187 patients previously treated with platinum chemotherapy, did not meet the evidentiary threshold required for accelerated approval.
The companies said they will continue the phase 3 IDeate-Lung02 study, which is close to completing enrollment, and may resubmit a broader data package later.
Merck expressed disappointment that the current dataset was insufficient for approval at this time.
This writeup was produced by pharmadog from original reporting by Fierce Biotech.
Original headline: “Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal”
read at Fierce Biotech ↗
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