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02/02/2022

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Results from the phase 3 MANGROVE trial supported FDA Priority Review of zanubrutinib plus rituximab for previously untreated mantle cell lymphoma, following a significant progression-free survival benefit compared with bendamustine plus...
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Acalabrutinib Plus Bendamustine and Rituximab Extends PFS and Delays Subsequent Therapy in Treatment-Naïve Patients With Mantle Cell Lymphoma
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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,...
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Sonrotoclax Monotherapy Demonstrates Meaningful Activity in Heavily Pretreated Mantle Cell Lymphoma
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Results from a phase 1/2 study showed that sonrotoclax monotherapy produced rapid and durable responses with a manageable safety profile in patients with relapsed or refractory mantle cell lymphoma previously treated with anti-CD20–based...
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In Vivo CAR T-Cell Therapy Shows Encouraging Early Activity in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
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Results from an ongoing phase 1 trial demonstrated that LB2501 shows encouraging activity and promising safety in patients with relapsed or refractory non-Hodgkin lymphomas.
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Results from the phase 1b/2 OrigAMI-4 trial supported FDA accelerated approval of subcutaneous amivantamab and hyaluronidase for previously treated recurrent or metastatic head and neck squamous cell carcinoma, introducing a dual...
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Varegacestat Advances Toward European Approval for Desmoid Tumors Following RINGSIDE Survival Benefit
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Based on results from the phase 3 RINGSIDE trial, the European Medicines Agency has validated the marketing authorization application for varegacestat in adults with desmoid tumors, following significant improvements in progression-free...
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Following FDA approval supported by the phase 1/2 ReFocus trial, lirafugratinib has been added to the NCCN Guidelines as a Category 2A preferred subsequent-line treatment option for patients with cholangiocarcinoma harboring FGFR2 fusions or...
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Pumitamig Plus Chemotherapy Shows Antitumor Activity Regardless of Brain Metastasis Status
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Results from two phase 2 trials demonstrated encouraging intracranial responses with pumitamig plus chemotherapy in patients with small cell lung cancer and triple-negative breast cancer with brain metastases, supporting further investigation...
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SEZ6-Targeted Antibody-Drug Conjugate ABBV-706 Demonstrates Promising Antitumor Activity in Relapsed or Refractory Small Cell Lung Cancer
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Updated phase 1 results demonstrated promising antitumor activity with the SEZ6-targeted antibody-drug conjugate ABBV-706 in relapsed or refractory small cell lung cancer, with encouraging response and survival outcomes alongside exploratory...
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Phase 1 Trial Shows 70% Response Rate With SKB500 in Heavily Pretreated Patients With Small Cell Lung Cancer
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Updated results from a phase 1 trial demonstrated promising antitumor activity with the B7-H3-directed antibody-drug conjugate SKB500 in heavily pretreated patients with small cell lung cancer, with the lower dose showing more favorable...
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Varegacestat Significantly Improves Pain, Physical Function, and Quality of Life in Patients With Desmoid Tumors
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Results from RINGSIDE trial demonstrated rapid and sustained improvements in patient-reported pain, desmoid-related symptoms, physical function, and quality of life with varegacestat compared with placebo in patients with progressing desmoid...
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FDA Alerts
Zanubrutinib Combination Receives FDA Priority Review Following Positive Phase 3 MANGROVE Results
11/04/2026
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Results from the phase 3 MANGROVE trial supported FDA Priority Review of zanubrutinib plus rituximab for previously untreated mantle cell lymphoma, following a significant progression-free survival benefit compared with bendamustine plus...
Results from the phase 3 MANGROVE trial supported FDA Priority Review of zanubrutinib plus rituximab for previously untreated mantle cell lymphoma, following a significant progression-free survival benefit compared with bendamustine plus...
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Medicare Expands Coverage of Signatera MRD Testing for Hepatocellular Carcinoma Surveillance
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Medicare coverage has been extended to serial Signatera molecular residual disease testing for surveillance of patients with early-stage hepatocellular carcinoma who have no evidence of disease following surgery, supported by real-world...
Medicare coverage has been extended to serial Signatera molecular residual disease testing for surveillance of patients with early-stage hepatocellular carcinoma who have no evidence of disease following surgery, supported by real-world...
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The 2026 NANETS Multidisciplinary NET Medical Symposium will spotlight emerging research, evolving treatment strategies, and practical insights to advance neuroendocrine tumor care.
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