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FDA Alerts
FDA Accepts New Drug Application for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer
07/23/2026
Stephanie Holland
The FDA accepted for review a New Drug Application for daraxonrasib in adults with previously treated metastatic pancreatic ductal adenocarcinoma based on the phase 3 RASolute 302 trial, which demonstrated improvements in overall survival,...
The FDA accepted for review a New Drug Application for daraxonrasib in adults with previously treated metastatic pancreatic ductal adenocarcinoma based on the phase 3 RASolute 302 trial, which demonstrated improvements in overall survival,...
The FDA accepted for review a...
07/23/2026
Oncology
News
Phase 3 MonumenTAL-6 Trial Demonstrates Significant Survival Benefit With Dual-Bispecific Immunotherapy in Relapsed or Refractory Multiple Myeloma
07/23/2026
Stephanie Holland
Results from the phase 3 MonumenTAL-6 trial demonstrated that teclistamab plus talquetamab significantly improved progression-free and overall survival compared with standard therapy in patients with relapsed or refractory multiple myeloma,...
Results from the phase 3 MonumenTAL-6 trial demonstrated that teclistamab plus talquetamab significantly improved progression-free and overall survival compared with standard therapy in patients with relapsed or refractory multiple myeloma,...
Results from the phase 3...
07/23/2026
Oncology
News
Magrolimab Plus Azacitidine Fails to Improve Outcomes in Higher-Risk Myelodysplastic Syndromes
07/22/2026
Stephanie Holland
The phase 3 ENHANCE trial demonstrated that magrolimab plus azacitidine did not improve complete remission or overall survival compared with azacitidine alone in treatment-naïve patients with higher-risk myelodysplastic syndromes and was...
The phase 3 ENHANCE trial demonstrated that magrolimab plus azacitidine did not improve complete remission or overall survival compared with azacitidine alone in treatment-naïve patients with higher-risk myelodysplastic syndromes and was...
The phase 3 ENHANCE trial...
07/22/2026
Oncology
News
Consolidative Thoracic Radiotherapy Increases Toxicity Without Survival Benefit in Extensive-Stage Small Cell Lung Cancer
07/22/2026
Stephanie Holland
Results from the phase 2 TREASURE trial demonstrated that adding consolidative thoracic radiotherapy to atezolizumab maintenance increased toxicity without improving survival in patients with extensive-stage small cell lung cancer, arguing...
Results from the phase 2 TREASURE trial demonstrated that adding consolidative thoracic radiotherapy to atezolizumab maintenance increased toxicity without improving survival in patients with extensive-stage small cell lung cancer, arguing...
Results from the phase 2...
07/22/2026
Oncology
FDA Approval
FDA Approves Zidesamtinib for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer
07/22/2026
Stephanie Holland
The FDA approved zidesamtinib for adults with previously treated locally advanced or metastatic ROS1-positive non-small cell lung cancer based on findings from the phase 1/2 ARROS-1 trial demonstrating durable responses, including in patients...
The FDA approved zidesamtinib for adults with previously treated locally advanced or metastatic ROS1-positive non-small cell lung cancer based on findings from the phase 1/2 ARROS-1 trial demonstrating durable responses, including in patients...
The FDA approved zidesamtinib...
07/22/2026
Oncology
News
Alpha DaRT® Plus Pembrolizumab Achieves 100% Response Rate in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
07/21/2026
Stephanie Holland
Results from a prospective study demonstrated that Alpha DaRT® combined with pembrolizumab achieved a 100% systemic objective response rate among evaluable patients with recurrent unresectable or metastatic head and neck squamous cell...
Results from a prospective study demonstrated that Alpha DaRT® combined with pembrolizumab achieved a 100% systemic objective response rate among evaluable patients with recurrent unresectable or metastatic head and neck squamous cell...
Results from a prospective study...
07/21/2026
Oncology
News
Safusidenib Demonstrates Durable Responses and Prolonged Disease Control in Grade 2 IDH1-Mutant Glioma
07/21/2026
Emily Estrada
Updated findings from the phase 2 J201 trial demonstrated that safusidenib, a selective mutant IDH1 inhibitor, produced durable responses and prolonged disease control in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant...
Updated findings from the phase 2 J201 trial demonstrated that safusidenib, a selective mutant IDH1 inhibitor, produced durable responses and prolonged disease control in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant...
Updated findings from the phase...
07/21/2026
Oncology
News
Indefinite Lenalidomide Maintenance Fails to Improve Overall Survival in Standard-Risk Multiple Myeloma
07/16/2026
Stephanie Holland
Results from the phase 3 ENDURANCE trial demonstrated that indefinite-duration lenalidomide maintenance therapy did not improve overall survival compared with 2 years of maintenance therapy in patients with standard-risk newly diagnosed...
Results from the phase 3 ENDURANCE trial demonstrated that indefinite-duration lenalidomide maintenance therapy did not improve overall survival compared with 2 years of maintenance therapy in patients with standard-risk newly diagnosed...
Results from the phase 3...
07/16/2026
Oncology
News
Dostarlimab Meets Primary End Point in Registrational AZUR-1 Trial for dMMR/MSI-H Rectal Cancer
07/16/2026
Stephanie Holland
Interim results from the registrational phase 2 AZUR-1 trial demonstrated that dostarlimab monotherapy achieved a clinically meaningful and durable clinical complete response in patients with stage II/III mismatch...
Interim results from the registrational phase 2 AZUR-1 trial demonstrated that dostarlimab monotherapy achieved a clinically meaningful and durable clinical complete response in patients with stage II/III mismatch...
Interim results from the...
07/16/2026
Oncology
FDA Approval
FDA Approves Gedatolisib-Based Regimens for PIK3CA Wild-Type HR-Positive, HER2-Negative Advanced Breast Cancer
07/14/2026
Stephanie Holland
The FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with PIK3CA wild-type HR-positive, HER2-negative advanced or metastatic breast cancer based on the phase 3 VIKTORIA-1 trial demonstrating...
The FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with PIK3CA wild-type HR-positive, HER2-negative advanced or metastatic breast cancer based on the phase 3 VIKTORIA-1 trial demonstrating...
The FDA approved gedatolisib in...
07/14/2026
Oncology

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