Read a refresh of breast cancer FDA news from August 2026, including an sNDA application in PIK3CA-mutant disease and a fast track designation.
News|Videos|June 30, 2025 (Updated: July 21, 2025)
Sacituzumab Govitecan Plus Pembrolizumab vs Chemotherapy Plus Pembrolizumab in Patients With Previously Untreated, PD-L1 Positive, Advanced or Metastatic Triple-Negative Breast Cancer: Primary Results From the Randomized, Phase 3 ASCENT-04/KEYNOTE-D19 Study
Author(s)Sara M. Tolaney, MD, MPH
Sara Tolaney, MD, MPH, presents primary results from the Phase 3 ASCENT-04/KEYNOTE-D19 study showing that sacituzumab govitecan plus pembrolizumab significantly improved progression-free survival with manageable safety versus chemotherapy plus pembrolizumab in previously untreated PD-L1–positive advanced triple-negative breast cancer.
Advertisement
Advertisement
Related to this article
Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.
The FDA granted final approval to aLutetium Lu 177 dotatate biosimilar for patients with SSTR-positive GEP-NETs.
The TrueBeam photon therapy system has been added to the Statesir Cancer Center at Atlantic Health CentraState Medical Center.
The addition of the β-catenin pathway inhibitor tegavivint to osimertinib produced deep responses in a phase 1b study in first-line EGFR-mutated NSCLC.
Updated NCCN guidelines now recommend rusfertide as a Category 1 option for both low- and high-risk polycythemia vera.
An observational analysis showed a long-term OS benefit with Orca-T in adult patients undergoing allogeneic transplantation for hematologic malignancies.
FDA has granted fast track designation to LYT-200 plus a hypomethylating agent in relapsed/refractory high-risk myelodysplastic syndromes.
Advertisement
Advertisement
Trending on OncLive
1
FDA Grants Fast Track Designation to LYT-200 in R/R High-Risk MDS
2
Japan Approves Subcutaneous Pembrolizumab for All Approved Pembrolizumab Indications
3
NAPISTAR-1-01 Data Support Rapid TUB-040 Development in Biomarker-Unrestricted Ovarian Cancer
4
Making Invisible Cancers Visible: Study Suggests a New Route to Turn ‘Cold’ Tumors ‘Hot’
5