In patients with high-risk HER2-positive breast cancer, post-surgery, or adjuvant, treatment with trastuzumab emtansine (T-DM1) reduced the long-term risk of death or invasive disease by 46% and ...
A team led by the Institute for Bioengineering of Catalonia (IBEC) and the Hospital del Mar Research Institute has developed ...
Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for ...
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
Given the evolving role of trastuzumab deruxtecan (Enhertu) in the treatment of breast cancer, especially those who are HER2 ...
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.
The addition of trastuzumab and pertuzumab to chemotherapy was associated with increased toxicity in patients with ...
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: ...
New approval brings the medicine to an earlier treatment setting and a broader patient population.
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...