Weekly Digest - October 2026
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - October 2026
25 September 2026: Ifinatamab deruxtecan BLA for previously treated extensive-stage SCLC was voluntarily withdrawn in the U.S.
- Daiichi Sankyo and MSD announced the voluntary withdrawal of the U.S. BLA seeking accelerated approval for Ifinatamab deruxtecan in adults with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy
- The withdrawal followed discussions with the FDA, which concluded that the available data supporting the application, including results from the phase 2 IDeate-Lung01 trial, did not meet the requirements for accelerated approval in the proposed indication
- The decision highlights the continuing unmet need in relapsed ES-SCLC, an aggressive cancer that progresses rapidly and has poor long-term survival, while subsequent treatment options after platinum-based chemotherapy remain limited
- Ifinatamab deruxtecan is a B7-H3-directed ADC comprising a humanized anti-B7-H3 IgG1 antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers
- Strategically, the withdrawal delays the potential U.S. entry of I-DXd in ES-SCLC, but does not halt development: enrollment continues in the phase 3 IDeate-Lung02 trial versus physician’s-choice chemotherapy, while phase 3 studies are also evaluating the ADC in castration-resistant prostate cancer and esophageal squamous cell carcinoma
