Allogeneic CAR T-Cell Product Shows Early Promise for Patients With CD30+ Lymphomas
May 17th 2021An off-the-shelf cellular therapy that combines Epstein Barr Virus–Specific T cells and a CD30-targeting chimeric antigen receptor product demonstrated safety and early efficacy in a group of patients with CD30-positive lymphomas.
Cemiplimab Improves OS Versus Chemotherapy Across Histologic Subtypes in Recurrent Cervical Cancer
May 14th 2021Results presented at part of the European Society for Medical Oncology Virtual Plenary show positive results of a phase 3 trial comparing cemiplimab with chemotherapy for previously treated cervical cancer.
Analysis Correlates Cost of Therapy With Improvement in Outcomes for Patients With HCC
May 12th 2021According to an economic evaluation, the use of atezolizumab plus bevacizumab is not cost effective versus sorafenib for the treatment of hepatocellular carcinoma when considering life-years gained and willingness-to-pay thresholds.
IND for CD20-Targeted CAR T-cell Therapy Is Accepted by FDA for R/R CLL
May 11th 2021MB-106, a CD20-targeted CAR T-cell therapy that has shown promise in the treatment of B-cell non-Hodgkin lymphoma, is now being considered for patients with relapsed or refractory CD20-positive chronic lymphocytic leukemia.
Datopotamab Deruxtecan Shows Promise in Heavily Pretreated Triple-Negative Breast Cancer
May 10th 2021The TROP2-directed antibody-drug conjugate datopotamab deruxtecan induced responses and an acceptable safety profile in a cohort of patients with triple-negative breast cancer treated on a phase 1 trial.
Motixafortide Reaches Primary End Point of Improved Stem Cell Mobilization in Multiple Myeloma Trial
May 5th 2021Statistical significance was reached across all end points of the phase 3 GENESIS trial investigating granulocyte colony stimulating factor plus either motixafortide or placebo in patients with multiple myeloma receiving autologous bone marrow transplantation.
New Drug Application Complete for Surufatinib to Treat Pancreatic/Extra-Pancreatic NETs
May 3rd 2021Rolling submission with the FDA for surufatinib treatment in patients with pancreatic and extra-pancreatic neoendocrume tumors was completed and an expanded access program for the drug is currently underway for patients in the United States.
Nivolumab Granted Priority Review as Adjuvant Therapy for Muscle-Invasive Urothelial Carcinoma
April 30th 2021Based on results of the recently reported phase 3 CheckMate 274 trial, the FDA has granted priority review designation to nivolumab for the adjuvant treatment of high-risk muscle-invasive bladder cancer.
FDA Committee Does Not Support Maintaining Accelerated Approval of Nivolumab for Advanced HCC
April 30th 2021By a close decision, the FDA’s Oncologic Drugs Advisory Committee voted against upholding the accelerated approval of nivolumab monotherapy to treat patients with hepatocellular carcinoma following sorafenib.
ODAC Decision Means Atezolizumab Will Maintain It’s Indication for Frontline Urothelial Carcinoma
April 29th 2021Accelerated approval for atezolizumab in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for certain chemotherapy regimens was maintained by an FDA committee vote.
FDA Grants Priority Review to Mobocertinib for EGFR Exon 20 Insertion+ Metastatic NSCLC
April 28th 2021Based on response efficacy in a phase 1/2 trial, the FDA granted the selective oral tyrosine kinase inhibitor mobocertinib priority review for patients with pretreated metastatic non–small cell lung cancer harboring insertion mutations in EGFR exon 20.