Items Tagged ‘FDA approval’

October 19th, 2015

Opdivo® Receives Expanded Approval for an Additional Type of Lung Cancer

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The United States Food and Drug Administration (FDA) has expanded the approval of Opdivo® (nivolumab) for the treatment of non-squamous, non-small cell lung cancer. Non-small cell lung cancer (NSCLC), the most common type of lung cancer, is divided into two main groups based upon the type of cells comprising the cancer: non-squamous and squamous cell. […]

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Tags: FDA approval, Lung Cancer - Non-Small Cell, News, nivolumab, non-small cell lung cancer, non-squamous, nsclc, opdivo, Stages I-IIIA Lung Cancer - Non-Small Cell


September 23rd, 2015

Iressa® Approved as Initial Therapy for Lung Cancer

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The targeted agent Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration (FDA) as initial therapy in the treatment of patients with advanced lung cancer. Specifically, Iressa was approved as initial therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with specific mutations within the EGFR pathway. The […]

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Tags: advanced lung cancer, EGFR mutations, EGFR RGQ PCR Kit, FDA approval, gefitinib, iressa, Lung Cancer - Non-Small Cell, News, nsclc, Stages IIIB-IV Lung Cancer - Non-Small Cell


July 20th, 2015

FDA Approves Iressa for Treatment of Patients with Metastatic Non Small Cell Lung Cancer

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The U. S. Food and Drug Administration approved IRESSA (gefitinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Gefitinib is being approved concurrently with a labeling expansion of […]

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Tags: FDA approval, gefitinib, Lung Cancer - Non-Small Cell, metastatic non-small cell lung cancer, News, nsclc, Stages IIIB-IV Lung Cancer - Non-Small Cell


April 9th, 2015

Unituxin® Approved for Treatment of Children with High-Risk Neuroblastoma

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The U.S. Food and Drug Administration (FDA) has announced the first-ever drug approval for the treatment of children with high-risk neuroblastoma. In clinical trials Unituxin® (dinutuximab) has improved survival among children with this type of cancer who have responded to previous treatment. Neuroblastoma is a type of cancer that develops in the nerve tissues of […]

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Tags: children, dinutuximab, FDA approval, high-risk, Neuroblastoma, News, Unituxin


March 11th, 2015

Novel PD-1 Inhibitor Opdivo Approved for Treatment of Lung Cancer

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The Food and Drug Administration has expanded approval of the PD-1 inhibitor Opdivo® (nivolumab) to include treatment of patients who have metastatic squamous non–small cell lung cancer (NSCLC) that progresses following treatment with platinum-based chemotherapy. Nivolumab belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to […]

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Tags: FDA approval, immune response, Lung Cancer, Lung Cancer - Non-Small Cell, metastatic squamous non-small cell lung cancer, nsclc, opdivo, PD-1 inhibitor, Recurrent Lung Cancer - Non-Small Cell


February 18th, 2015

Intravenous Administration of Erwinaze® Approved by FDA

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The U.S. Food and Drug Administration (FDA) recently approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi).  Erwinaze is utilized as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.1 Administration of Erwinaze through an intravenous infusion provides patients with hypersensitivity […]

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Tags: Acute Lymphoblastic Leukemia, all, asparaginase, asparaginase Erwinia chrysanthemi, Erwinaze, FDA approval, Leukemia, leukemia treatment, News