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FDA Approval
FDA Approves Belzutifan Plus Lenvatinib Following Immunotherapy in Advanced Clear Cell Renal Cell Carcinoma
09/24/2026
Emily Estrada
Based on results from the LITESPARK-011 trial, the FDA has approved belzutifan plus lenvatinib following PD-1 or PD-L1 inhibitor therapy for patients with advanced clear cell renal cell carcinoma, providing a new combination treatment option...
Based on results from the LITESPARK-011 trial, the FDA has approved belzutifan plus lenvatinib following PD-1 or PD-L1 inhibitor therapy for patients with advanced clear cell renal cell carcinoma, providing a new combination treatment option...
Based on results from the...
09/24/2026
Oncology
Conference Coverage
Acalabrutinib Plus Bendamustine and Rituximab Extends PFS and Delays Subsequent Therapy in Treatment-Naïve Patients With Mantle Cell Lymphoma
09/24/2026
Emily Estrada
Updated results from the phase 3 ECHO trial demonstrated that adding acalabrutinib to bendamustine and rituximab prolonged progression-free survival and delayed subsequent treatment in older patients with treatment-naïve mantle cell lymphoma,...
Updated results from the phase 3 ECHO trial demonstrated that adding acalabrutinib to bendamustine and rituximab prolonged progression-free survival and delayed subsequent treatment in older patients with treatment-naïve mantle cell lymphoma,...
Updated results from the phase 3...
09/24/2026
Oncology
News
Zidesamtinib Shows Durable Systemic and Intracranial Activity in Patients With TKI-Naïve ROS1-Positive Non-Small Cell Lung Cancer
09/24/2026
Emily Estrada
Results from the ARROS-1 trial demonstrated that zidesamtinib produced high and durable systemic and intracranial response in TKI-naïve patients with advanced ROS1-positive non-small cell lung cancer, supporting continued investigation of the...
Results from the ARROS-1 trial demonstrated that zidesamtinib produced high and durable systemic and intracranial response in TKI-naïve patients with advanced ROS1-positive non-small cell lung cancer, supporting continued investigation of the...
Results from the ARROS-1 trial...
09/24/2026
Oncology
FDA Alerts
FDA Advisory Committee Backs Galleri Multi-Cancer Early Detection Test for Adults Aged 50 Years and Older
09/24/2026
Stephanie Holland
An FDA advisory committee voted in favor of GRAIL’s Galleri multi-cancer early detection test for adults aged 50 years and older, supporting its safety, effectiveness, and overall benefit-risk profile as the agency continues review of its...
An FDA advisory committee voted in favor of GRAIL’s Galleri multi-cancer early detection test for adults aged 50 years and older, supporting its safety, effectiveness, and overall benefit-risk profile as the agency continues review of its...
An FDA advisory committee voted...
09/24/2026
Oncology
FDA Approval
FDA Approves Lirafugratinib for Previously Treated FGFR2-Altered Cholangiocarcinoma
09/23/2026
Emily Estrada
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the...
09/23/2026
Oncology
FDA Approval
FDA Approves Bravnetsa as Bioequivalent and Therapeutically Equivalent Lutetium Lu 177 Dotatate for SSTR-Positive GEP-NETs
09/23/2026
Stephanie Holland
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for...
09/23/2026
Radiopharmaceutical Education Institute
FDA Approval
FDA Approves and Launches Generic Lanreotide Injection Referencing Somatuline Depot
09/23/2026
Stephanie Holland
The FDA approved Amneal’s lanreotide injection referencing Somatuline Depot for acromegaly, advanced gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome, expanding availability of the long-acting somatostatin analog across...
The FDA approved Amneal’s lanreotide injection referencing Somatuline Depot for acromegaly, advanced gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome, expanding availability of the long-acting somatostatin analog across...
The FDA approved Amneal’s...
09/23/2026
Oncology
News
NHS-Galleri Trial Finds No Significant Reduction in Stage III or IV Cancer With Multicancer Blood Screening
09/23/2026
Stephanie Holland
Results from the randomized NHS-Galleri trial showed that adding blood-based multicancer early-detection testing to usual care did not significantly reduce the incidence of late-stage cancers compared with usual care alone, although fewer...
Results from the randomized NHS-Galleri trial showed that adding blood-based multicancer early-detection testing to usual care did not significantly reduce the incidence of late-stage cancers compared with usual care alone, although fewer...
Results from the randomized...
09/23/2026
Oncology
News
NCCN Recommends Rusfertide as Category 1 Option Across Low- and High-Risk Polycythemia Vera
09/22/2026
Stephanie Holland
Updated NCCN Guidelines recommend rusfertide as a Category 1 treatment option across low- and high-risk polycythemia vera, incorporating the first-in-class hepcidin mimetic into clinical management following findings demonstrating hematocrit...
Updated NCCN Guidelines recommend rusfertide as a Category 1 treatment option across low- and high-risk polycythemia vera, incorporating the first-in-class hepcidin mimetic into clinical management following findings demonstrating hematocrit...
Updated NCCN Guidelines...
09/22/2026
Oncology
News
FDA Grants Fast Track Designation to LYT-200 Plus Hypomethylating Therapy for Relapsed or Refractory High-Risk Myelodysplastic Syndromes
09/22/2026
Emily Estrada
The FDA granted Fast Track designation to LYT-200 plus a hypomethylating agent for relapsed or refractory high-risk myelodysplastic syndromes following early-phase findings demonstrating clinical activity and supporting advancement of the...
The FDA granted Fast Track designation to LYT-200 plus a hypomethylating agent for relapsed or refractory high-risk myelodysplastic syndromes following early-phase findings demonstrating clinical activity and supporting advancement of the...
The FDA granted Fast Track...
09/22/2026
Oncology

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