August 2020

FDA Approves New Therapy for Relapsed/Refractory Mantle Cell Lymphoma 
On July 24, 2020, the FDA announced the accelerated approval of brexucabtagene autoleucel (Tecartus), previously recognized as KTE-X19. This agent is the first and only chimeric antigen receptor (CAR) T-cell therapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Brexucabtagene autoleucel is classified as a CD19-directed genetically modified autologous T-cell immunotherapy and is available as a cell suspension for infusion. Read more

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FDA Grants Fast Track Status for Enzastaurin
On July 17, 2020, the manufacturer of enzastaurin announced that the FDA granted fast track designation for DB102 (enzastaurin), a protein kinase C (PKC) beta inhibitor for the treatment of patients with newly diagnosed glioblastoma. Enzastaurin is formulated as an oral investigational first-in-class, small-molecule, serine/threonine kinase inhibitor of the PKC beta, PI3K, and AKT pathways that has been studied in more than 3,000 patients across a variety of solid and hematological tumor types. Read more. Read more.  

Teriparatide Efficacious for Medication-Related Osteonecrosis of the Mandible  
In a recent article in the Journal of Clinical Oncology, Sim et al explored the efficacy and safety of using a 2-month course of teriparatide therapy in healing established medication-related osteonecrosis of the jaw (MRONJ) lesions in patients with cancer or osteoporosis. In this double blind, randomized, controlled trial, 34 participants with established MRONJ were evaluated. Approximately 80% of patients had received antiresorptive therapy for malignant bone disease. Read more.

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