30/05/2026
Stay ahead of the curve with our weekly roundup, featuring 5️⃣ key developments in oncology—regulatory decisions, pivotal trial updates, and pipeline shifts shaping cancer care.
🎗️ FDA Approves Dato-DXd ( ) in PD-1/PD-L1–Ineligible Metastatic TNBC: The Agency approved the TROP2-directed ADC for triple-negative breast cancer patients ineligible for immunotherapy, backed by significant OS and PFS improvements over chemotherapy in the phase 3 TROPION-Breast02 trial.
🫁 Priority Review Granted to Sevabertinib in First-Line HER2-Mutant NSCLC: The FDA accepted the NDA for sevabertinib based on a 71% ORR and a not-yet-reached median PFS in treatment-naive patients with HER2-mutant NSCLC in the phase 1/2 SOHO-01 trial.
🔵 sBLA Accepted for Nogapendekin Alfa Inbakicept ( ) Plus BCG in Papillary-Only NMIBC: The FDA will review the expanded bladder cancer indication with a January 2027 PDUFA date, potentially making this the first approved bladder-sparing therapy for BCG-unresponsive papillary-only disease.
🧬 Fast Track Granted to Suplexa in MSI-H Colorectal Cancer: This non-engineered autologous cellular immunotherapy showed durable responses exceeding 80 weeks and a clean safety profile in the first-in-human SUPLEXA-101 study, supporting a planned phase 2 trial with checkpoint inhibitors.
🩸 Orphan Drug Designation for CLN-049 in Relapsed/Refractory AML: The FLT3xCD3 T-cell engager earned orphan status on the strength of phase 1 data showing a 57% ORR at therapeutic doses, adding to its existing FDA fast track designation in this difficult-to-treat setting.
Catch up on the full recap: https://hubs.li/Q04hLn9F0
