WebJun 5, 2024 · In April 2024, the FDA granted Breakthrough Therapy Designation for T-DXd in HER2-low metastatic breast cancer. T-DXd is also being studied in multiple other … WebSep 7, 2024 · The FDA approved a new drug to treat HER2-Low breast cancer, a hard-to-treat subtype of breast cancer. The drug, Enhertu, combines two potent medications for a targeted approach to attack cancer ...
FDA Approves First Targeted Therapy for HER2-Low …
WebJun 10, 2024 · The novel HER2-directed antibody-drug conjugate (ADC) trastuzumab deruxtecan-nxki (Enhertu; DS-8201) demonstrated promising antitumor activity in patients with heavily pretreated, HER2 low ... WebDec 14, 2024 · Background About 50% of all primary breast cancers show a low-level expression of HER2 (HER2-low), defined as immunohistochemically 1+ or 2+ and lack of HER2 gene amplification measured by in situ hybridization. This low HER2 expression is a promising new target for antibody–drug conjugates (ADCs) currently under investigation. … posen piet
FDA Grants Breakthrough Therapy Designation for Trastuzumab …
WebA new era of HER2-low treatment is upon us. Thanks to a landmark FDA approval, AstraZeneca and Daiichi Sankyo's Enhertu has become the first therapy targeted to treat HER2-low breast cancer. WebApr 27, 2024 · The FDA has granted a breakthrough therapy designation to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received a ... WebMay 1, 2024 · The FDA has granted breakthrough therapy designation to fam-trastuzumab deruxtecan-nxki (Enhertu) for adults with unresectable HER2-low metastatic breast cancer and who have received prior treatment in the metastatic setting or developed disease recurrence within 6 months of adjuvant chemotherapy completion, according to a press … hanna rakete