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FDA Approval
09/09/2026
Stephanie Holland
The FDA expanded the accelerated approval of sevabertinib to adults with locally advanced or metastatic non-squamous non-small cell lung cancer harboring HER2 activating mutations, extending the targeted therapy into the first-line setting...
The FDA expanded the accelerated approval of sevabertinib to adults with locally advanced or metastatic non-squamous non-small cell lung cancer harboring HER2 activating mutations, extending the targeted therapy into the first-line setting...
The FDA expanded the accelerated...
09/09/2026
Oncology
FDA Approval
09/08/2026
Emily Estrada
Based on results from the phase 3 SERENA-6 trial, the FDA granted accelerated approval to camizestrant plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer following detection of an ESR1 mutation during ongoing...
Based on results from the phase 3 SERENA-6 trial, the FDA granted accelerated approval to camizestrant plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer following detection of an ESR1 mutation during ongoing...
Based on results from the phase...
09/08/2026
Oncology
News
09/03/2026
Stephanie Holland
Early-phase results showed that daraxonrasib produced meaningful antitumor activity across dose levels in previously treated advanced RAS-mutant non–small cell lung cancer, supporting further evaluation of this oral RAS(ON) multiselective...
Early-phase results showed that daraxonrasib produced meaningful antitumor activity across dose levels in previously treated advanced RAS-mutant non–small cell lung cancer, supporting further evaluation of this oral RAS(ON) multiselective...
Early-phase results showed that...
09/03/2026
Oncology
News
09/03/2026
Stephanie Holland
Topline results from the phase 3 CERVINO trial showed that etentamig significantly improved response and progression-free survival over standard available therapies in triple-class exposed relapsed or refractory multiple myeloma, supporting...
Topline results from the phase 3 CERVINO trial showed that etentamig significantly improved response and progression-free survival over standard available therapies in triple-class exposed relapsed or refractory multiple myeloma, supporting...
Topline results from the phase 3...
09/03/2026
Oncology
News
09/02/2026
Stephanie Holland
Results from the phase 3 HARMONi trial showed that ivonescimab plus chemotherapy improved progression-free survival compared with chemotherapy alone in patients with advanced EGFR-mutated NSCLC after progression on third-generation EGFR...
Results from the phase 3 HARMONi trial showed that ivonescimab plus chemotherapy improved progression-free survival compared with chemotherapy alone in patients with advanced EGFR-mutated NSCLC after progression on third-generation EGFR...
Results from the phase 3 HARMONi...
09/02/2026
Oncology
News
09/02/2026
Stephanie Holland
Updated results from the phase 3 AEGEAN trial showed that perioperative durvalumab plus neoadjuvant chemotherapy maintained an event-free survival benefit compared with neoadjuvant chemotherapy alone in patients with resectable non-small cell...
Updated results from the phase 3 AEGEAN trial showed that perioperative durvalumab plus neoadjuvant chemotherapy maintained an event-free survival benefit compared with neoadjuvant chemotherapy alone in patients with resectable non-small cell...
Updated results from the phase 3...
09/02/2026
Oncology
News
09/01/2026
Stephanie Holland
Five-year results from the phase 3 KEYNOTE-671 trial showed that perioperative pembrolizumab plus neoadjuvant chemotherapy provided durable event-free and overall survival benefits compared with neoadjuvant chemotherapy and surgery alone in...
Five-year results from the phase 3 KEYNOTE-671 trial showed that perioperative pembrolizumab plus neoadjuvant chemotherapy provided durable event-free and overall survival benefits compared with neoadjuvant chemotherapy and surgery alone in...
Five-year results from the phase...
09/01/2026
Oncology
News
08/31/2026
Emily Estrada
Topline results from the phase 2a NEO100-01 trial showed that intranasal NEO100 achieved a 48.9% 6-month progression-free survival rate in patients with recurrent IDH1-mutant high-grade glioma, significantly exceeding the prespecified 20%...
Topline results from the phase 2a NEO100-01 trial showed that intranasal NEO100 achieved a 48.9% 6-month progression-free survival rate in patients with recurrent IDH1-mutant high-grade glioma, significantly exceeding the prespecified 20%...
Topline results from the phase...
08/31/2026
Oncology
News
08/31/2026
Stephanie Holland
Updated phase 3 HERIZON-GEA-01 results showed that zanidatamab-based regimens improved overall survival compared with trastuzumab plus chemotherapy in first-line HER2-positive advanced gastroesophageal adenocarcinoma, strengthening the...
Updated phase 3 HERIZON-GEA-01 results showed that zanidatamab-based regimens improved overall survival compared with trastuzumab plus chemotherapy in first-line HER2-positive advanced gastroesophageal adenocarcinoma, strengthening the...
Updated phase 3 HERIZON-GEA-01...
08/31/2026
Oncology
News
08/31/2026
Emily Estrada
A real-world study of nirogacestat in patients with desmoid tumors demonstrated durable disease control, tumor responses, and meaningful pain improvement, with many patients also reducing or discontinuing analgesics, reinforcing the clinical...
A real-world study of nirogacestat in patients with desmoid tumors demonstrated durable disease control, tumor responses, and meaningful pain improvement, with many patients also reducing or discontinuing analgesics, reinforcing the clinical...
A real-world study of...
08/31/2026
Oncology