FAILED TRIAL: Ph 3 PRESERVE 2 Trial of Trilaciclib Before 1L chemo in mTNBC did Not Achieve Statistical Significance in the Primary Endpoint of OS July 1, 2024
Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer based on CAPItello-291 results June 25, 2024
FAILED TRIAL: CAPItello-290 Ph 3 trial of Truqap (capivasertib) + chemo in locally advanced, inoperable or metastatic TNBC patients with PI3KCA/AKT1/PTEN alterations did not meet the dual primary endpoints of OS improvement June 25, 2024
FDA grants Priority Review to inavolisib for advanced HR+ve, HER2-neg breast cancer with a PIK3CA mutation June 4, 2024
First Patient Enrolled in AFFIRM-205, a Ph III Study of LAE002 (afuresertib) + Fulvestrant for Treatment of Breast Cancer June 3, 2024
FDA grants Breakthrough Therapy Designation to inavolisib for advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation May 29, 2024
Updated Clinical Data from Ph 1b Trial of Vepdegestrant + Palbociclib (IBRANCE) Announced May 21, 2024
Intensity Therapeutics and The Swiss Group for Clinical Cancer Research SAKK to Conduct a Ph 2 Randomized Trial in Early-Stage Breast Cancer in Europe for INT230-6 May 14, 2024
Enhertu demonstrated statistically significant and clinically meaningful PFS improvement in HR+ve, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Ph 3 trial May 1, 2024
Feedback from FDA following Type B meeting encourages clinical development of rupitasertib in advanced breast cancer May 1, 2024
Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer May 1, 2024
Atossa Therapeutics and Quantum Leap Healthcare Announce I-SPY 2 Clinical Trial to Evaluate (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer April 16, 2024
Novartis implements manufacturing adjustments for ribociclib to ensure alignment with latest regulatory standards in eBC by end of Q2 April 16, 2024
Type C Meeting Requested to FDA Toward Registration-Enabling Trial for Pelareorep in Breast Cancer April 16, 2024
Datopotamab deruxtecan BLA accepted in the US for patients with previously treated metastatic HR+ve, HER2-neg breast cancer April 8, 2024
Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer April 2, 2024
FDA Allows to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer March 26, 2024
BriaCell Receives and Executes Letter of Intent to Advance Clinical Development of Breast and Prostate Cancer Immunotherapies March 12, 2024
Two Datopotamab Deruxtecan Applications Validated in the EU for Patients with Advanced Nonsquamous NSCLC or HR+, HER2 Negative Breast Cancer March 12, 2024
