FDA approves new breast cancer treatment
The new drug is meant to treat specific types of advanced breast cancer which are resistant to hormone therapy.
Cure Today4d
Breaking Down Cancer Therapies Approved by the FDA in January 2025
Here is a select list of cancer therapies approved by the FDA throughout the month of January, featuring patient populations ...
FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
Hosted on MSN1d
A New 'Missile' Drug Is Approved To Treat the Most Common Breast Cancer Type
Fact checked by Nick Blackmer The Food and Drug Administration (FDA) recently approved a new targeted chemotherapy drug for ...
Cure Today11d
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 ...
Targeted Oncology2d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
FDA approves Datroway for HR-positive, HER2-negative breast cancer
The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...
Pharm Exec4d
FDA Approves Expanded Label for Roche's Companion Diagnostic to Identify HER2-Ultralow Breast Cancer Patients Eligible for Enhertu
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Targeted Oncology2d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
The American Journal of Managed Care7d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Healio11d
FDA expands Enhertu approval for breast cancer
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...
MedPage Today11d
FDA Expands Enhertu Approval to HER2-Ultralow Breast Cancer
gained approval in 2022 for unresectable or metastatic HER2-low breast cancer -- defined by an FDA-approved test as IHC 1+ or IHC 2+/in situ hybridization (ISH)‑. This approval included patients ...