FDA Fast Track Designation for ETX-19477 for the Treatment of Patients with BRCA-Mutated, HR+/HER2- Unresectable or Metastatic Breast Cancer August 25, 2026
Vepdegestrant Now Available for U.S. Patients With ER+/HER2-, ESR1-Mutated Advanced or Metastatic Breast Cancer August 20, 2026
Evexta Bio and Roche to Evaluate Rupitasertib in Combination with a Selective Estrogen Receptor Degrader in Advanced/Metastatic Breast Cancer August 11, 2026
Newly FDA-Approved REVTORPYK™ (gedatolisib) Included in the NCCN Clinical Practice Guidelines for HR+/HER2- Locally Advanced or Metastatic Breast Cancer August 5, 2026
Datroway approved in the EU for 1L metastatic TNBC patients not candidates for immunotherapy August 5, 2026
Enhertu + pertuzumab recommended for approval in the EU by CHMP in 1L HER2-positive metastatic breast cancer July 28, 2026
BeOne Medicines Expands U.S. Manufacturing with More Than $1 Billion Investment to Advance Cancer Medicines July 28, 2026
Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1L advanced ER-positive breast cancer July 28, 2026
Patient Treatment Restarted in Ph 2 INVINCIBLE-4 Study of Neoadjuvant INT230-6 in TNBC Patients July 21, 2026
FDA Approves REVTORPYK (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA WT Locally Advanced or Metastatic Breast Cancer July 15, 2026
Astex Announces Exclusive Research Collaboration and License Agreement with Genentech for Breast Cancer Therapy Program July 7, 2026
FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ≥10) Advanced TNBC June 30, 2026
Datroway recommended for approval in the EU by CHMP for patients with 1L metastatic TNBC who are not candidates for immunotherapy June 30, 2026
FDA Approves IBRANCE Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline Maintenance June 30, 2026
First Patient Enrolled in Ph 1b/2 Breast Cancer Study of AK138D1 Combined with Ivonescimab June 17, 2026
Ph 3 trial of Anbenitamab (KN026) + Docetaxel For Injection (Albumin-Bound) (HB1801) For 1L HER2+ve Advanced Breast Cancer Meets Primary Endpoint June 17, 2026
FDA accepts NDA for giredestrant in ER+ve early-stage breast cancer with positive Ph 3 results in the curative setting June 10, 2026
Ona Therapeutics Raises $86.6 Million Series B to Advance First-in-Class ADCs into Clinical Development June 10, 2026
Positive Recommendation from DSMB for Ph 3 Study of Bria-IMT + CPI in Metastatic Breast Cancer June 2, 2026
