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HER2 News

News
12/04/2025
Stephanie Holland
Results from the phase 1/2 SOHO-01 trial demonstrate that sevabertinib, an anti-HER2 tyrosine kinase inhibitor, shows promising antitumor activity among patients with locally advanced or metastatic HER2-mutated non–small cell lung cancer...
Results from the phase 1/2 SOHO-01 trial demonstrate that sevabertinib, an anti-HER2 tyrosine kinase inhibitor, shows promising antitumor activity among patients with locally advanced or metastatic HER2-mutated non–small cell lung cancer...
Results from the phase 1/2...
12/04/2025
Oncology
FDA Approval
11/19/2025
Emily Estrada
The FDA has granted accelerated approval to sevabertinib for adults with locally advanced or metastatic non-squamous non–small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations who have received prior systemic...
The FDA has granted accelerated approval to sevabertinib for adults with locally advanced or metastatic non-squamous non–small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations who have received prior systemic...
The FDA has granted accelerated...
11/19/2025
Oncology
FDA Approval
11/13/2025
Stephanie Holland
The FDA approved pertuzumab-dpzb as the first interchangeable pertuzumab biosimilar for the treatment of patients with HER2-positive metastatic breast cancer.
The FDA approved pertuzumab-dpzb as the first interchangeable pertuzumab biosimilar for the treatment of patients with HER2-positive metastatic breast cancer.
The FDA approved pertuzumab-dpzb...
11/13/2025
Oncology
News
11/07/2025
Stephanie Holland
Results from the phase 2 AMALEE trial show that a 400 mg starting dose of ribociclib, combined with a nonsteroidal aromatase inhibitor, reduced dose-dependent adverse events while maintaining efficacy vs the standard dose in HR-positive,...
Results from the phase 2 AMALEE trial show that a 400 mg starting dose of ribociclib, combined with a nonsteroidal aromatase inhibitor, reduced dose-dependent adverse events while maintaining efficacy vs the standard dose in HR-positive,...
Results from the phase 2 AMALEE...
11/07/2025
Oncology
News
10/29/2025
Stephanie Holland
Primary analysis results from the phase 3 CULMINATE-2 trial show that adding culmerciclib to fulvestrant significantly improves outcomes among previously untreated patients with HR-positive, HER2-negative locally advanced or metastatic breast...
Primary analysis results from the phase 3 CULMINATE-2 trial show that adding culmerciclib to fulvestrant significantly improves outcomes among previously untreated patients with HR-positive, HER2-negative locally advanced or metastatic breast...
Primary analysis results from...
10/29/2025
Oncology
News
10/18/2025
Stephanie Holland
Results from the phase 3 DESTINY-Breast05 trial show trastuzumab deruxtecan significantly improved invasive disease-free survival compared to trastuzumab emtansine among patients with HER2-positive early breast cancer.
Results from the phase 3 DESTINY-Breast05 trial show trastuzumab deruxtecan significantly improved invasive disease-free survival compared to trastuzumab emtansine among patients with HER2-positive early breast cancer.
Results from the phase 3...
10/18/2025
Oncology
News
10/18/2025
Janelle Bradley
Neoadjuvant trastuzumab deruxtecan plus trastuzumab, pertuzumab, and docetaxel (T-DXd-THP) significantly improved pathologic complete response rates (pCR), showed early favorable event-free survival, and reduced severe toxicity compared to...
Neoadjuvant trastuzumab deruxtecan plus trastuzumab, pertuzumab, and docetaxel (T-DXd-THP) significantly improved pathologic complete response rates (pCR), showed early favorable event-free survival, and reduced severe toxicity compared to...
Neoadjuvant trastuzumab...
10/18/2025
Oncology
FDA Approval
09/25/2025
Stephanie Holland
The FDA has approved imlunestrant for patients with ER-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations.
The FDA has approved imlunestrant for patients with ER-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations.
The FDA has approved...
09/25/2025
Oncology
News
09/25/2025
Allison Casey
In a phase 2 study, MRG002 demonstrated manageable safety profile and promising anti-tumor activity among patients with locally advanced or metastatic breast cancer with low HER2 expression.
In a phase 2 study, MRG002 demonstrated manageable safety profile and promising anti-tumor activity among patients with locally advanced or metastatic breast cancer with low HER2 expression.
In a phase 2 study, MRG002...
09/25/2025
Oncology
News
09/12/2025
Stephanie Holland
Sequential HER2-targeted therapy following trastuzumab deruxtecan discontinuation demonstrated clinical promise among patients with HER2-positive metastatic breast cancer who responded to T-DXd however discontinued treatment due to adverse...
Sequential HER2-targeted therapy following trastuzumab deruxtecan discontinuation demonstrated clinical promise among patients with HER2-positive metastatic breast cancer who responded to T-DXd however discontinued treatment due to adverse...
Sequential HER2-targeted therapy...
09/12/2025
Oncology