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FDA Approval
FDA Approves Atezolizumab for Patients with ctDNA-Positive Muscle-Invasive Bladder Cancer
05/15/2026
Emily Estrada
Based on results from the IMvigor011 trial, the FDA has approved adjuvant atezolizumab and atezolizumab plus hyaluronidase for ctDNA-positive patients with muscle-invasive bladder cancer.
Based on results from the IMvigor011 trial, the FDA has approved adjuvant atezolizumab and atezolizumab plus hyaluronidase for ctDNA-positive patients with muscle-invasive bladder cancer.
Based on results from the...
05/15/2026
Oncology
News
BTX-9341 Shows Promising Efficacy, Safety in HR-Positive, HER2-Negative Advanced Breast Cancer
05/15/2026
Emily Estrada
Results from the phase 1 BTX-9341-101 trial demonstrated that BTX-9341 shows encouraging efficacy and safety in heavily pretreated patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Results from the phase 1 BTX-9341-101 trial demonstrated that BTX-9341 shows encouraging efficacy and safety in heavily pretreated patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Results from the phase 1...
05/15/2026
Oncology
News
pCR Guided Chemotherapy De-Escalation Shows Promise in HER2-Positive Early Breast Cancer
05/15/2026
Emily Estrada
A chemotherapy-free, pCR-guided strategy with dual HER2 blockade achieved high response rates and preserved quality of life in patients with HER2-positive early breast cancer.
A chemotherapy-free, pCR-guided strategy with dual HER2 blockade achieved high response rates and preserved quality of life in patients with HER2-positive early breast cancer.
A chemotherapy-free, pCR-guided...
05/15/2026
Oncology
News
Zongertinib Demonstrates Clinical Promise in HER2-Mutated Non-Small Cell Lung Cancer
05/14/2026
Stephanie Holland
First-line treatment with zongertinib showed sustained efficacy in advanced or metastatic HER2-mutated non-small-cell lung cancer, according to results from the phase 1a/1b Beamion LUNG-1 trial.
First-line treatment with zongertinib showed sustained efficacy in advanced or metastatic HER2-mutated non-small-cell lung cancer, according to results from the phase 1a/1b Beamion LUNG-1 trial.
First-line treatment with...
05/14/2026
Oncology
FDA Alerts
FDA Issues Safety Alert on Tazemetostat Following Secondary Malignancy Risk
05/13/2026
Emily Estrada
The FDA issued a safety alert regarding tazemetostat, citing an increased risk of hematologic second primary malignancies observed in the ongoing SYMPHONY-1 trial.
The FDA issued a safety alert regarding tazemetostat, citing an increased risk of hematologic second primary malignancies observed in the ongoing SYMPHONY-1 trial.
The FDA issued a safety alert...
05/13/2026
Oncology
FDA Approval
FDA Approves Sonrotoclax for Patients With Relapsed/Refractory Mantle Cell Lymphoma
05/13/2026
Emily Estrada
Based on results from the BGB-11417-201 trial, the FDA has approved sonrotoclax for previously treated patients with relapsed/refractory mantle cell lymphoma.
Based on results from the BGB-11417-201 trial, the FDA has approved sonrotoclax for previously treated patients with relapsed/refractory mantle cell lymphoma.
Based on results from the...
05/13/2026
Oncology
FDA Approval
FDA Approves Oral Decitabine and Cedazuridine Plus Venetoclax for Newly Diagnosed Acute Myeloid Leukemia
05/13/2026
Janelle Bradley
The FDA granted approval to the first fully oral regimen of decitabine and cedazuridine plus venetoclax for adults with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
The FDA granted approval to the first fully oral regimen of decitabine and cedazuridine plus venetoclax for adults with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
The FDA granted approval to the...
05/13/2026
Oncology
News
Tucatinib Plus T-DM1 Shows Sustained Disease Control in HER2-Positive Advanced Breast Cancer
05/13/2026
Emily Estrada
Final results from the phase 3 HER2CLIMB-02 trial demonstrated that tucatinib plus T-DM1 improved PFS in patients with HER2-Positive locally advanced or metastatic breast cancer, including those with brain metastases.
Final results from the phase 3 HER2CLIMB-02 trial demonstrated that tucatinib plus T-DM1 improved PFS in patients with HER2-Positive locally advanced or metastatic breast cancer, including those with brain metastases.
Final results from the phase 3...
05/13/2026
Oncology
News
Trastuzumab Deruxtecan Plus Paclitaxel, Trastuzumab, and Pertuzumab Improves Residual Cancer Burden in HER2-Positive Early Breast Cancer
05/11/2026
Stephanie Holland
Post hoc analysis results from the phase 3 DESTINY-Breast11 trial demonstrated that neoadjuvant trastuzumab deruxtecan plus paclitaxel, trastuzumab, and pertuzumab improved residual cancer burden and pathologic response in HER2-positive early...
Post hoc analysis results from the phase 3 DESTINY-Breast11 trial demonstrated that neoadjuvant trastuzumab deruxtecan plus paclitaxel, trastuzumab, and pertuzumab improved residual cancer burden and pathologic response in HER2-positive early...
Post hoc analysis results from...
05/11/2026
Oncology
News
Sacituzumab Govitecan Plus Trastuzumab Showed Limited Activity After T-DXd in HER2-Positive Metastatic Breast Cancer
05/11/2026
Stephanie Holland
According to results from the phase 2 SATEEN trial, sacituzumab govitecan plus trastuzumab demonstrated limited clinical activity in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab deruxtecan.
According to results from the phase 2 SATEEN trial, sacituzumab govitecan plus trastuzumab demonstrated limited clinical activity in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab deruxtecan.
According to results from the...
05/11/2026
Oncology

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