Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety of tumors.
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for H
FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer.
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: NCT04494425 ).
FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster drug as a second-line treatment for patients with HER2-low and HER2-ultralow metastatic breast cancer.
Itovebi-Based Treatment Has OS Benefit in PIK3CA+ HR+/HER2– Breast Cancer
Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated positive overall survival results.
FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU
AstraZeneca Receives FDA Approval for Enhertu Breast Cancer Treatment
AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical company said Monday that the treatment's approval was based on results from a Phase III trial,
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy.
AstraZeneca's Enhertu gets additional FDA approval
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) drug Enhertu has been approved by the FDA for the treatment of certain breast cancer patients. Enhertu was approved for the treatment of unresectable or metastatic HR-positive,
In HER2+ colorectal cancer, anti-HER2 therapy may be less toxic alternative
Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...
FierceBiotech1d
Roche drops HER2 bispecific, Xencor-partnered cytokine from early-phase pipeline
Roche has given two early-phase bispecifics the heave-ho, ending work on a HER2xCD3 prospect and an IL-15 candidate it picked ...
Targeted Oncology1d
A New AI Tool Assists Pathologists in Assessing HER2 0 vs 1+ in Breast Cancer
Pathologists supported by a new artificial intelligence tool outperformed Standard of Care/Gold standard in determining ...