Merck and Daiichi Sankyo Pull Ifinatamab Deruxtecan BLA Amidst Continued Phase 3 Trial

Merck and Daiichi Sankyo's ifinatamab deruxtecan, a potential first-in-class B7-H3 directed ADC for treating small cell lung cancer (SCLC), has seen its Biologics License Application (BLA) voluntarily withdrawn by the companies.

The decision to withdraw the BLA was made after discussions with the US FDA, which stated that data from the IDeate-Lung01 phase 2 trial did not meet the requirements needed for accelerated approval in the proposed indication.

Despite this setback, patient enrollment continues in the ongoing IDeate-Lung02 phase 3 trial, which is evaluating ifinatamab deruxtecan against chemotherapy in patients with relapsed SCLC. The companies are hopeful that results from this trial will provide further data to support a future filing with the FDA and other global regulatory authorities.