FAILED TRIAL: persevERA Breast Cancer study of giredestrant-palbociclib combo did not meet the primary objective of statistically significant PFS improvement in ER+ve, HER2-neg locally advanced or metastatic breast cancer March 10, 2026
Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2+ve early breast cancer March 10, 2026
NMPA Accepts New Drug Applications for Toripalimab Subcutaneous Injection Across 12 Indications March 10, 2026
Positive Ph 3 Interim Topline Results for izalontamab brengitecan (Iza-bren) in Unresectable Locally Advanced or Metastatic 1L TNBC Highlighted March 3, 2026
FDA Fast Track Designation for ART6043 for Treatment of gBRCA-mutated HER2-Negative Breast Cancer March 3, 2026
ENHERTU® Supplemental NDA Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer March 3, 2026
FDA accepts NDA for giredestrant in ESR1-mutated, ER+ advanced breast cancer; PDUFA Dec 2026 February 25, 2026
Sensei Biotherapeutics Announces Acquisition of Faeth Therapeutics and $200M Concurrent Private Placement February 25, 2026
ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2+ve Early Breast Cancer February 25, 2026
DATROWAY Supplemental NDA Submitted in Japan for Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy February 25, 2026
Zovegalisib Granted Breakthrough Therapy Designation by FDA for PIK3CA-mutant, HR+/HER2- Advanced Breast Cancer February 9, 2026
DATROWAY® Granted Priority Review in the US in 1L Metastatic TNBC Patients Who Are Not Candidates for Immunotherapy February 9, 2026
Multiple Sites Activated for Ph 1b/2 Trial of AMXT 1501 and DFMO in Patients with solid tumors including Breast Cancer and Melanoma February 9, 2026
New Data Demonstrate CD47 Expression Level Helps Predict Response to Evorpacept in Combination with Ziihera in HER2+ve Breast Cancer February 1, 2026
Trodelvy® Added as Preferred Regimen Within 1L Metastatic TNBC in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) February 1, 2026
NEJM Publishes Ph 3 ASCENT-04/KEYNOTE-D19 Results of Trodelvy + Keytruda in 1L PD-L1+ Metastatic TNBC January 25, 2026
ENHERTU + Pertuzumab Type II Variation Application Validated in the EU in 1L HER2+ve Metastatic Breast Cancer January 25, 2026
Bio-Sourcing, Zerion Pharma to Collaborate on First HER2 Oral Monoclonal Antibody for Breast Cancer January 18, 2026
