FDA Approves Pembrolizumab Combination for Cervical Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1). The FDA has also granted regular approval to single-agent pembrolizumab for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1, with a combined positive score of ≥1, who experienced disease progression on or after c...
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Abemaciclib Plus Endocrine Therapy Approved for Early Breast Cancer

The FDA has approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with endocrine therapy consisting of an aromatase inhibitor or tamoxifen as adjuvant therapy for patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, node-positive early breast cancer with a high risk of recurrence. Abemaciclib, the first CDK4/6 inhibitor to be approved in the adjuvant breast cancer setting, is indicated for patients with a Ki-67 score of ≥20%. In...
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Brexucabtagene Autoleucel Approved: Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

The FDA has approved brexucabtagene autoleucel (TecartusTM, Kite Pharma), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, for patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). "Despite treatment with novel therapies and allogeneic stem cell transplant consolidation, outcomes in adult patients with relapsed or refractory B-cell precursor ALL remain poor, underlining the need for more effective therapies," wrote Bijal D. Shah, MD, Ass...
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FDA Approves Cetuximab Plus Encorafenib for Metastatic Colorectal Cancer

 The FDA has granted approval to cetuximab (Erbitux®, Eli Lilly), in combination with encorafenib (Braftovi®, Array BioPharma) for the treatment of patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. "Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy," wrote Scott Kopetz, MD, PhD, FACP, Professor in the Department of Gastrointestinal Medical ...
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FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease

The FDA has approved ruxolitinib (Jakafi®, Incyte) for adult and pediatric patients 12 year of age and older with chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy."Chronic graft-versus-host disease, a major complication of allogeneic stem cell transplantation, becomes glucocorticoid-refractory or glucocorticoid-dependent in approximately 50% of patients," wrote Robert Zeiser, MD, Professor and Head of the Tumor Immunology and Immune Modulation at th...
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