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Showing 1 - 8FDA Approves Entrectinib for NTRK-Fusion Cancers, ROS1-Positive NSCLC
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek) for adult and adolescent patients whose cancers have an NTRK (neurotrophic tyrosine receptor kinase) genetic fusion and for whom there are no effective treatments. Entrectinib was also...
FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression
On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation. “This is the first treatment...
FDA Approves Crizotinib for ROS1-Positive Metastatic NSCLC
The U.S. Food and Drug Administration today approved the tyrosine kinase inhibitor crizotinib (Xalkori) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients...
FDA Approves Alectinib for Advanced ALK-Positive NSCLC
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to alectinib (Alecensa) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are intolerant to crizotinib (Xalkori). ...
FDA Approves Osimertinib for EGFR T790M Mutation–Positive Non–Small Cell Lung Cancer After Progression on Prior EGFR-Blocking Therapy
The U.S. Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non–small cell lung cancer (NSCLC). Osimertinib (Tagrisso) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation ...
FDA Approves Use of Nivolumab in Advanced Nonsquamous Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved nivolumab (Opdivo) to treat patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) whose disease progressed during or after platinum-based chemotherapy. Nivolumab is a monoclonal antibody that that blocks the...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell...
FDA Approves Afatinib for EGFR-mutant Late-stage Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) today approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21...
