Patients should be selected for treatment with Enhertu in combination with pertuzumab based on confirmed HER2-positive status or HER2 gene amplification (IHC 3+ or ISH+).
Disclaimer: Trastuzumab deruxtecan has not been approved by the FDA for the neoadjuvant or adjuvant setting for early-stage, ...
FDA approval moves trastuzumab deruxtecan in combination with pertuzumab into frontline treatment of unresectable or ...
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved additional indications for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary ...
The FDA's approval is based on results from the Phase III DESTINY-Breast09 trial, in which the combo showed a median 40.7-month progression-free survival.
The U.S. Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with ...
The FDA approved T-DXd plus pertuzumab for HER2-positive metastatic breast cancer, based on DESTINY-Breast09 trial results. The combination therapy reduced disease progression or death risk by 44% ...
The Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki, or Enhertu from Daiichi Sankyo (DSNKY), in combination with pertuzumab ...
A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate shows an approximately 80% reduction in recurrence rate in the fully enrolled, 250 patient ...
In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple ...
Previous findings from the phase 3 DESTINY-Breast05 study (NCT04622319) showed that T-DXd demonstrated statistically significant and clinically meaningful improvement vs T-DM1 in the primary endpoint ...
The FDA has granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors ...
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