Tag: trastuzumab

The U.S. Food and Drug Administration (FDA) has approved additional indications for the Roche PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests.

Now positive topline results from a new study, the DESTINY-Breast11 phase 3 trial (NCT05113251), confirmed that trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)**, followed by paclitaxel, trastuzumab and pertuzumab (THP), demonstrated a statistically significant and clinically meaningful improvement in pCR rate versus Standard-of-Care (SoC; dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.

Positive topline results from a planned interim analysis of the phase 3 DESTINY-Breast09 (NCT04784715) trial showed trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)* in combination with pertuzumab (Perjeta®; Genentech/Roche) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab (Herceptin®; Genentech/Roche) and pertuzumab (THP) as a first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer.

The use of trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca), a new HER2-targeting antibody-drug conjugate, doubled progression-free survival (PFS) compared to standard-of-care treatment with...

The U.S. Food and Drug Administration (FDA) has approved fam-trastuzumab deruxtecan-nxki (Enhertu®; Daiichi Sankyo and AstraZeneca) for the treatment of adult patients with unresectable or metastatic HER2...

José Baselga, MD, Ph.D., an internationally renowned expert in the development of molecular targeted agents, the R&D chief at AstraZeneca, who had earlier been...

As part of a new study focusing on advanced targeting human epidermal growth factor receptor-2 (HER2-) expressing cancers, including locally advanced or metastatic solid...

San Francisco Bay Area-based Bolt Biotherapeutics confirmed that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant...

In a statement earlier today, Daiichi Sankyo confirmed that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour...

Earlier this week Daiichi Sankyo announced plans to accelerate filing of their Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)...