FDA Approves Belumosudil for Chronic Graft-Versus-Host Disease

The FDA has granted approval to belumosudil (Rezurock™, Kadmon Pharmaceuticals, LLC), for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. "Belumosudil (KD025) is a novel oral selective Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor specifically designed for the treatment of chronic GVHD," wrote Corey S. Cutler, MD, MPH, FRCPC, Medical Director of the Adult Stem Cell Transplantation...
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Nivolumab/Cabozantinib for Renal Cell Carcinoma: David Braun, MD, PhD, and Wenxin (Vincent) Xu, MD

Recently, the results of a phase 3 trial on nivolumab/cabozantinib were published in the New England Journal of Medicine. The study (CheckMate 9ER) compared the efficacy and safety of nivolumab/cabozantinib with those of sunitinib in adult patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The trial results demonstrated that nivolumab/cabozantinib has significant benefits over sunitinib in this patient population. In this interview with Oncology Data Advisor, Dr. ...
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Idecabtagene Vicleucel FDA Approved for Relapsed/Refractory Multiple Myeloma

The FDA has approved idecabtagene vicleucel (Abecma®, Bristol Myers Squibb) for patients with relapsed or refractory multiple myeloma who have already been treated with four or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. "Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic ef...
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FDA Approves Axicabtagene Ciloleucel for Relapsed/Refractory Follicular Lymphoma

The FDA has granted accelerated approval to axicabtagene ciloleucel (Yescarta®, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. An indolent form of non-Hodgkin lymphoma (NHL) that is not generally curable, FL is considered a chronic disease. Therefore, people living with FL often require second-line therapies after their di...
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Melphalan Flufenamide Approved for Triple-Class Refractory Multiple Myeloma

The FDA has approved melphalan flufenamide (Pepaxto®, Oncopeptides AB) in combination with dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy and whose disease is refractory to at least one CD38–directed monoclonal antibody, one proteasome inhibitor, and one immunomodulatory agent. "Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapid...
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