FDA Approvals - Cancer Currents Blog
News on recent approvals of cancer therapies by the Food and Drug Administration. Includes expert comments on how the approval will influence patient care and future research.
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The FDA has approved a new formulation of rituximab, Rituxan Hycela, that reduces treatment administration time for patients with several types of blood cancer.
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The FDA has approved the targeted therapy ceritinib as an initial treatment for patients with lung cancer that has a mutation in the ALK gene.
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FDA approved pembrolizumab for patients with solid tumors that have specific genetic features, called mismatch repair deficiency and high microsatellite instability. This is the first approval based on a genetic feature, rather than cancer type.
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FDA approved the immune checkpoint inhibitor pembrolizumab to be used with chemotherapy as a first-line treatment for non-small cell lung cancer.
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The FDA has approved midostaurin for patients with newly diagnosed acute myeloid leukemia (AML) with mutations in the FLT3 gene. The approval also covers several rare conditions.
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The FDA has approved four immunotherapy drugs—avelumab, atezolizumab, durvalumab, and pembrolizumab—for the treatment of patients with bladder cancer. All four drugs belong to a class of cancer therapies known as checkpoint inhibitors.
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FDA approved the kinase inhibitor regorafenib for some patients with hepatocellular carcinoma, the most common form of liver cancer.
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On April 28, the FDA granted accelerated approval to the targeted therapy brigatinib (Alunbrig™) for patients with metastatic non-small cell lung cancer (NSCLC) and alterations in the ALK gene whose cancer has progressed during their initial therapy.
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The FDA approved pembrolizumab for the treatment of some adult and pediatric patients with classical Hodgkin lymphoma.
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The FDA approved the PARP inhibitor niraparib for use as a maintenance therapy for some women with advanced ovarian cancer.