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 Niraparib as Maintenance Therapy for Recurrent Ovarian Cancer
The 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 Cancer
The 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 Carcinoma
The 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 Myeloma
The 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 Cancer
The 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 Cancer
The 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 Myeloma
The 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 Cancer
The 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 Cancer
The 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 Sarcoma
The 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 Cancer
FDA 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 Biopsy
The 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 Cancer
The 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 Cancer
The 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 Lymphoma
A 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 Leukemia
The FDA has approved venetoclax for patients with chronic lymphocytic leukemia whose tumors have a specific genetic alteration.
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Crizotinib Approval Expanded for Advanced Lung Cancer
The FDA has approved uses of the targeted therapy crizotinib (Xalkori®) for patients with advanced lung cancer whose tumors have alterations in the ROS1 gene.
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FDA Approves Eribulin Mesylate for Advanced Liposarcoma
The FDA has approved eribulin mesylate for patients with liposarcoma whose cancers are advanced or cannot be removed by surgery and are no longer responding to anthracycline-based chemotherapy.
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FDA Approves Alectinib for ALK-Positive Non-Small Cell Lung Cancer
The FDA has approved alectinib to treat patients with metastatic ALK-positive non-small cell lung cancer who have stopped responding to or who are unable to tolerate crizotinib.
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Three New Therapies Approved for Multiple Myeloma
In November 2015, the FDA approved three new therapies for patients with multiple myeloma.