FDA Approves Atezolizumab for Non–Small Cell Lung Cancer

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech) for the adjuvant treatment of patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have a programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells. Atezolizumab is approved for use following resection and platinum-based chemotherapy in this patient population.The FDA has also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems), a diagnostic device that will select patients with...
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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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