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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
FDA Approval
FDA Grants Traditional Approval to Selpercatinib for RET Fusion-Positive Solid Tumors
07/14/2026
Stephanie Holland
The FDA granted traditional approval to selpercatinib for adults and children aged 2 years and older with previously treated RET fusion-positive solid tumors based on durable responses observed across multiple tumor types in the LIBRETTO-001...
The FDA granted traditional approval to selpercatinib for adults and children aged 2 years and older with previously treated RET fusion-positive solid tumors based on durable responses observed across multiple tumor types in the LIBRETTO-001...
The FDA granted traditional...
07/14/2026
Oncology
News
De-escalated Paclitaxel, Trastuzumab, and Pertuzumab Yield Excellent Long-Term Outcomes in HER2-Positive Breast Cancer
07/14/2026
Stephanie Holland
A prespecified analysis of the phase 2 DAPHNe trial demonstrated that abbreviated neoadjuvant paclitaxel, trastuzumab, and pertuzumab produced excellent 5-year outcomes in stage II to III HER2-positive breast cancer, while ultrasensitive...
A prespecified analysis of the phase 2 DAPHNe trial demonstrated that abbreviated neoadjuvant paclitaxel, trastuzumab, and pertuzumab produced excellent 5-year outcomes in stage II to III HER2-positive breast cancer, while ultrasensitive...
A prespecified analysis of the...
07/14/2026
Oncology
FDA Approval
FDA Approves Pegfilgrastim Biosimilar ENNUMO for the Prevention of Febrile Neutropenia and Treatment of Acute Radiation Syndrome
07/13/2026
Stephanie Holland
The FDA approved ENNUMO, a biosimilar to pegfilgrastim, for the same indications as the reference product, providing an additional granulocyte colony-stimulating factor option to reduce febrile neutropenia during myelosuppressive chemotherapy...
The FDA approved ENNUMO, a biosimilar to pegfilgrastim, for the same indications as the reference product, providing an additional granulocyte colony-stimulating factor option to reduce febrile neutropenia during myelosuppressive chemotherapy...
The FDA approved ENNUMO, a...
07/13/2026
Oncology
FDA Alerts
FDA Accepts New Drug Application for Mezigdomide Combination in Relapsed or Refractory Multiple Myeloma
07/13/2026
Stephanie Holland
The FDA accepted the new drug application for mezigdomide plus carfilzomib and dexamethasone for relapsed or refractory multiple myeloma based on phase 3 SUCCESSOR-2 results demonstrating a significant progression-free survival benefit...
The FDA accepted the new drug application for mezigdomide plus carfilzomib and dexamethasone for relapsed or refractory multiple myeloma based on phase 3 SUCCESSOR-2 results demonstrating a significant progression-free survival benefit...
The FDA accepted the new drug...
07/13/2026
Oncology
News
Trastuzumab Rezetecan Improves Progression-Free Survival in Previously Treated HER2-Positive Metastatic Breast Cancer
07/10/2026
Stephanie Holland
Interim results from the phase 3 HORIZON-Breast01 trial demonstrated that trastuzumab rezetecan significantly improved progression-free survival compared with pyrotinib plus capecitabine in patients with previously treated HER2-positive...
Interim results from the phase 3 HORIZON-Breast01 trial demonstrated that trastuzumab rezetecan significantly improved progression-free survival compared with pyrotinib plus capecitabine in patients with previously treated HER2-positive...
Interim results from the phase...
07/10/2026
Oncology
FDA Approval
FDA Approves Subcutaneous Isatuximab Across Multiple Indications for Patients With Multiple Myeloma
07/10/2026
Emily Estrada
The FDA has approved subcutaneous isatuximab for three treatment indications in multiple myeloma, including in combination with pomalidomide and dexamethasone, carfilzomib and dexamethasone, or bortezomib, lenalidomide, and dexamethasone.
The FDA has approved subcutaneous isatuximab for three treatment indications in multiple myeloma, including in combination with pomalidomide and dexamethasone, carfilzomib and dexamethasone, or bortezomib, lenalidomide, and dexamethasone.
The FDA has approved...
07/10/2026
Oncology
News
Performance Status Predicts Real-World Outcomes With Tarlatamab in Extensive-Stage Small Cell Lung Cancer
07/09/2026
Stephanie Holland
A multicenter real-world study identified ECOG performance status as a key determinant of outcomes with tarlatamab in extensive-stage small cell lung cancer, with patients who had preserved functional status achieving survival comparable to...
A multicenter real-world study identified ECOG performance status as a key determinant of outcomes with tarlatamab in extensive-stage small cell lung cancer, with patients who had preserved functional status achieving survival comparable to...
A multicenter real-world study...
07/09/2026
Oncology

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