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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FDA Approves Immunotherapy Drugs for Patients with Bladder CancerThe 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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Regorafenib Becomes First FDA-Approved Drug for Liver Cancer in Nearly a DecadeFDA approved the kinase inhibitor regorafenib for some patients with hepatocellular carcinoma, the most common form of liver cancer.
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FDA Grants Brigatinib Accelerated Approval for Metastatic Non-Small Cell Lung CancerOn 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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FDA Approves Pembrolizumab for Hodgkin LymphomaThe FDA approved pembrolizumab for the treatment of some adult and pediatric patients with classical Hodgkin lymphoma.
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FDA Approves Niraparib as Maintenance Therapy for Recurrent Ovarian CancerThe FDA approved the PARP inhibitor niraparib for use as a maintenance therapy for some women with advanced ovarian cancer.
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FDA Approves Ribociclib, Expands Palbociclib Approval for Metastatic Breast CancerThe FDA has approved a new targeted therapy, ribociclib, and expanded its earlier approval of another targeted therapy, palbociclib, for some women with metastatic breast cancer.
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Avelumab Becomes First Approved Treatment for Patients with Merkel Cell CarcinomaThe FDA has approved the first drug ever for the rare skin cancer, Merkel cell carcinoma, and updated data show an improved tumor response rate and that patients’ tumors continued to respond for at least a year.
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FDA Approves New Use for Lenalidomide in Multiple MyelomaThe FDA has approved lenalidomide for use as a maintenance therapy in patients with multiple myeloma who have undergone an autologous stem cell transplant, to help keep the cancer from coming back.
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FDA Approves Nivolumab for Bladder CancerThe FDA has approved nivolumab for the treatment of unresectable locally advanced or metastatic bladder cancer that worsened after treatment with platinum-based chemotherapy.
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FDA Approves Rucaparib for BRCA-Positive Ovarian CancerThe FDA has approved rucaparib for women with BRCA-positive advanced ovarian cancer based on findings from two small clinical trials showing that it shrank tumors.
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FDA Approves New Use for Daratumumab in Multiple MyelomaThe FDA has approved daratumumab, in combination with either of two other standard therapies, in patients with multiple myeloma whose disease has progressed after only a single prior treatment course.
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FDA Approves Nivolumab for Head and Neck CancerThe FDA has approved nivolumab for squamous cell carcinoma of the head and neck that has progressed during chemotherapy with a platinum-based drug or that has recurred or metastasized after platinum-based chemotherapy.
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More Immunotherapy Options Approved for Lung CancerThe FDA has approved atezolizumab and expanded the approval of pembrolizumab for some patients with non-small cell lung cancer.
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Olaratumab Approved to Treat Advanced Soft Tissue SarcomaThe Food and Drug Administration (FDA) has granted accelerated approval to olaratumab (Lartruvo®) for the treatment of some patients with soft tissue sarcoma.
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FDA Approves Pembrolizumab for Head and Neck CancerFDA granted pembrolizumab an accelerated approval for patients with recurrent or metastatic head and neck cancer that has continued to progress despite standard treatment with chemotherapy.
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Blood Test for Genetic Changes in Tumors Shows Promise as Alternative to Tumor BiopsyThe largest study of its kind to date has shown that a test that assesses DNA mutations and other changes in genetic material shed from tumors into the blood—a liquid biopsy—produced results highly similar to those of traditional tumor biopsies.
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FDA Approves New Immunotherapy Drug for Bladder CancerThe FDA has approved atezolizumab (Tecentriq®) for the treatment of some patients with urothelial carcinoma, the most common type of bladder cancer.
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Two New Therapies Approved by FDA for Advanced Kidney CancerThe FDA has approved two drugs, cabozantinib and lenvatinib, for patients whose advanced kidney cancers have progressed after prior treatment with antiangiogenic therapies.
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FDA Approves First Immunotherapy for LymphomaA blog post on the FDA approval of the immunotherapy drug nivolumab for the treatment of some patients with Hodgkin lymphoma.
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Venetoclax Approved for Some Patients with Chronic Lymphocytic LeukemiaThe FDA has approved venetoclax for patients with chronic lymphocytic leukemia whose tumors have a specific genetic alteration.