FDA Approves a New HER2-targeted Therapeutic for Breast Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA) approved a new molecularly targeted therapeutic called neratinib (Nerlynx) for treating certain patients with HER2-positive breast cancer. Specifically, the FDA approved neratinib for reducing disease recurrence in patients with early-stage HER2-positive breast cancer who have completed postsurgery (adjuvant) treatment with trastuzumab (Herceptin) and whose disease has not progressed.

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A Targeted Therapy Next in Line for Biomarker-based Cancer Drug Approval?

recent data suggest that there is another potential contender for a biomarker-based FDA approval: a targeted therapeutic called larotrectinib (LOXO-101), which showed promising results in adults and children with a variety of cancer types, all of which had one thing in common – fusions involving the gene TRK.

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Do Genomic Approaches to Selecting Cancer Treatment Yield Better Patient Outcomes Than Traditional Approaches?

A study published recently in the AACR’s journal Cancer Discovery addresses the burgeoning question of the utility of high-throughput genomic analysis in identifying targeted therapies and delivering better outcomes for cancer patients, and adds important evidence to argue in favor of such an approach. The jury, nevertheless, is still out.

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FDA Approves Fourth ALK Inhibitor for Lung Cancer

Last week, a flurry of U.S. Food and Drug Administration (FDA) oncology approvals concluded with the approval of the molecularly targeted therapeutic brigatinib (Alunbrig) for treating certain patients with metastatic non–small cell lung cancer (NSCLC).

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New Therapeutic Approved by FDA to Treat Breast Cancer

Earlier this week, the U.S. Food and Drug Administration approved the molecularly targeted therapeutic ribociclib (Kisqali) for use in combination with any aromatase inhibitor for initial treatment of postmenopausal women with a hormone receptor (HR)–positive, HER2-negative, advanced breast cancer.

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