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


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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