Enhertu granted Priority Review in the US for patients with HER2-low/ultralow metastatic breast cancer who received at least one line of endocrine therapy October 8, 2024
Key Progress and Upcoming Studies for Pelareorep Breast and Pancreatic Cancer Treatments Announced in Preparation for FDA Accelerated Approval Path October 8, 2024
ENHERTU® Supplemental NDA Submitted in Japan for Patients with HER2 Low/ultralow Metastatic Breast Cancer October 8, 2024
Regor Enters into a Definitive Purchase Agreement for Genentech to Acquire Regor’s Portfolio of next-gen CDK inhibitors for Treating Breast Cancer October 2, 2024
FAILED TRIAL: Datopotamab deruxtecan did not achieve statistical significance for OS vs chemo in patients with metastatic HR+, HER2-low or neg breast cancer in TROPION-Breast01 Ph 3 trial September 24, 2024
Favorable Results Reported for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study September 24, 2024
FDA-Authorized Expanded Access Policy for Metastatic Breast Cancer Patients Announced September 24, 2024
FDA approves Kisqali to reduce risk of recurrence in people with HR+/HER2- early breast cancer September 24, 2024
Median OS of 15.6 months in Ph 2 Bria-IMT™ study patients treated in combination with CPI announced September 17, 2024
Positive Interim Data for RLY-2608 Demonstrating Clinically Meaningful PFS announced September 17, 2024
Avenzo Therapeutics Announces Clinical Study Collaboration with Gilead Sciences to Evaluate AVZO-021 and Trodelvy® in HR+/HER2- Metastatic Breast Cancer September 10, 2024
Enrollment Completed in Ph 2 I-SPY 2 Arm Evaluating Lasofoxifene in Neoadjuvant Breast Cancer Setting September 3, 2024
Nadunolimab clinical trials in AML/MDA and TNBC to be initiated in Q4 2024 and H2 2025, respectively September 3, 2024
First Patient dosed in I-SPY 2 Trial Combining (Z)-Endoxifen with Abemaciclib for ER+/HER2- Breast Cancer August 27, 2024
ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Certain Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer August 22, 2024
ENHERTU Type II Variation Application Validated by EMA for Patients with HER2 Low or Ultralow Metastatic Breast Cancer Following At Least One Endocrine Therapy August 22, 2024
Enrollment of 80mg PK Run-In Cohort in Ph 2 EVANGELINE Trial of (Z)-Endoxifen as a Neoadjuvant Treatment for ER+ / HER2- Breast Cancer Completed July 30, 2024
Sermonix Pharmaceuticals Receives U.S. Patent for Lasofoxifene as Method for Treating Aromatase-Resistant ER+ Breast Cancer in the Absence of ESR1 Mutations July 23, 2024
Updated Protocol for Clinical Trial Evaluating (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer Announced July 9, 2024
Type C meeting with FDA supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC) concluded July 1, 2024
