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FDA Roundup: May 2020 Novel Drug Approvals

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Capmatinib (Tabrecta)
On May 6, 2020, the FDA approved capmatinib (Tabrecta) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14. This is the first approval of a treatment for MET Exon 14+ metastatic NSCLC.

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Selpercatinib (Retevmo)
On May 8, 2020, the FDA approved selpercatinib (Retevmo) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer and the treatment of adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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Ripretinib (Qinlock)
On May 15, 2020, the FDA has approved ripretinib (Qinlock) tablets as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), indicated for adult patients who have received prior treatment with ≥3 kinase inhibitor therapies.

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Artesunate (Amivas)
On May 26, 2020, the FDA approved artesunate for injection (Amivas) for the treatment of severe malaria in adult and pediatric patients. This is the only drug approved in the United States to treat severe malaria.

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Tauvid (flortaucipir F 18 injection)
On May 28, 2020, the FDA approved flortaucipir F 18 injection (Tauvid) to image tau pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease. The radioactive diagnostic agent is used in PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles.

Read more here.

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