Bristol Myers Squibb Withdraws Nivolumab Indication for Treatment of SCLC
January 4th 2021Nivolumab was previously granted accelerated approval by the FDA for the treatment of patients with small cell lung cancer (SCLC) whose disease had progressed after platinum-based chemotherapy and at least 1 other line of therapy, but phase 3 trial results led to a decision to withdraw the indication.
FDA Approves Osimertinib as Adjuvant Therapy Following Resection of NSCLC with EGFR Mutations
December 18th 2020Full approval has been granted by the FDA to osimertinib (Tagrisso) for use as adjuvant therapy following tumor resection among patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
Phase 3 ATLANTIS Study Fails to Meet Primary End Point of OS for Patients with SCLC
December 3rd 2020The study evaluated lurbinectedin (Zepzelca) in combination with doxorubicin versus physician's choice of topotecan or cyclophosphamide/doxorubicin/vincristine for adult patients with small cell lung cancer whose disease progressed following 1 prior platinum-containing line of therapy.
Osimertinib Extends Disease-Free Survival in Resected EGFR-Mutated NSCLC in Phase 3 ADAURA Trial
November 21st 2020These study results suggest that osimertinib as adjuvant therapy is an effective treatment strategy for patients with stage IB to IIIA EGFR-positive non-small cell lung cancer following complete tumor resection.
FDA Approves Additional Dosing Option of Durvalumab for Stage III NSCLC, Advanced Bladder Cancer
November 20th 2020The FDA approved a 1500 mg fixed dose of durvalumab (Imfinzi) administered every 4 weeks for the treatment of unresectable stage III non-small cell lung cancer after chemoradiation therapy and previously treated advanced bladder cancer.
Proton Radiotherapy in Patients with LA-NSCLC May Aid in Reducing Risk of Heart Disease
November 14th 2020This study found that found that mini-strokes and heart attacks were significantly less common among patients with locally advanced non-small cell lung cancer who underwent proton therapy versus conventional photon-based radiation therapy.
Study Identifies Characteristics of CAR T-Cell Products Associated with Outcomes in LBCL
October 7th 2020Researchers identified molecular and cellular characteristics of anti-CD19 CAR T-cell infusion products associated with how patients with large B-cell lymphoma respond to treatment and experience adverse events.
FDA Clears Phase 1 Clinical Trial of ATA2271 for Treatment of Advanced Mesothelioma
September 15th 2020The FDA accepted an investigational new drug application providing clearance to begin an open-label, single-arm phase 1 clinical trial of ATA2271, a next-generation mesothelin targeting CAR T-cell therapy.
FDA Grants Breakthrough Therapy Designation to Osimertinib for Early-Stage EGFR+ NSCLC
July 30th 2020The FDA granted breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
FDA Grants Breakthrough Therapy Designation, Orphan Drug Designation to MK-6482
July 29th 2020The FDA granted breakthrough therapy designation to MK-6482 for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma and orphan drug designation to MK-6482 for von Hippel-Lindau disease.
Phase 2 CITYSCAPE Trial Shows Promise for Tiragolumab in NSCLC
July 4th 2020Patients with chemotherapy-naïve, locally advanced, or metastatic non-small cell lung cancer who were treated with tiragolumab plus an anti-PD-L1 agent showed better efficacy versus single-agent checkpoint inhibitor therapy alone.
Economic Evaluation of CAR T-Cell Therapies by Site Care for Large B-Cell Lymphomas
April 16th 2020Researchers found that the potential availability of CAR T-cell therapies for large B-cell lymphomas with lower adverse event rates that are suitable for outpatient administration may reduce the total costs of care.
FDA Grants Priority Review to KTE-X19 for Treatment of Mantle Cell Lymphoma
February 10th 2020The biologic license application is supported by data from the phase II ZUMA-2 trial, which is currently assessing the CAR T-cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Early Findings Show Promise of CAR NK-Cell Therapy in Leukemia, Lymphoma
February 8th 2020Patients with either relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia treated with CAR NK cells had a response without the development of cytokine release syndrome, neurotoxicity, or graft-versus-host disease.
Additional Data Reported for Ongoing Phase I/II AUTO3 Clinical Trials Treating DLBCL
February 4th 2020The data was presented at the EHA-EBMT 2nd European CAR T-Cell Meeting, which took place on January 30, 2020 in Barcelona, Spain, and showed encouraging signs of a manageable safety profile in adults with relapsed/refractory DLBCL.
Biologics License Application Submitted for Mantle Cell Lymphoma CAR T-Therapy KTE-X19
December 17th 2019The submission to the FDA for the investigational CAR T-cell therapy is based on data from the phase II ZUMA-II trial for the treatment of adult patients with relapsed/refractory mantle cell lymphoma.