AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Gilead Sciences announced that the European Commission has approved Trodelvy as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors, based on the landmark Phase 3 ASCENT-03 study.
The Phase III SERENA-6 trial reveals that switching to AstraZeneca Camizestrant Breast Cancer Treatment yields a 55% reduction in disease progression risk for advanced HR-positive breast cancer patients with emergent ESR1 mutations.
Roche announces FDA Priority Review for giredestrant, the first oral SERD showing positive phase III results in the curative, adjuvant setting for ER-positive early breast cancer.
Trodelvy mTNBC (sacituzumab govitecan-hziy) has reached a pivotal regulatory milestone in the European Union. On May 22, 2026, Gilead Sciences announced that the Committee for [Read More…]
Datroway FDA approval for TNBC was officially granted today, marking a transformative shift in the management of one of the most aggressive forms of breast [Read More…]
Atirmociclib Phase 2 data released mark a potentially defining moment in the treatment of hormone receptor-positive metastatic breast cancer. Pfizer’s investigational CDK4 inhibitor demonstrated a statistically [Read More…]
While Roche’s persevERA trial didn’t meet its primary endpoint, the pharmaceutical company remains committed to advancing giredestrant as a new standard-of-care endocrine therapy. The FDA has accepted the company’s New Drug Application based on positive evERA data, signaling promise for this ER-positive breast cancer treatment.
Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.
Roche’s Itovebi™ (inavolisib) significantly improved overall survival in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer patients, according to final Phase III INAVO120 trial results.
