Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
T-DM1 sustained the improvement in invasive disease-free survival over trastuzumab in HER2-positive early breast cancer.
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 ...
Patients whose metastatic colorectal cancer has progressed following chemotherapy and who lack mutations in the RAS and BRAF ...
Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for ...
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I using Herceptin SC? Herceptin SC contains the active ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
Th e GINECO trial explored the combination of trastuzumab with paclitaxel and carboplatin in patients with resistant AOC (< 6 months) and HER2 gene amplification. Patients and Methods: A total of ...
In the HER2-low population, treatment with trastuzumab deruxtecan reduced the risk of disease progression or death by 38% compared with chemotherapy. The Food and Drug Administration (FDA ...
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