FDA Approvals - Cancer Currents Blog
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FDA Expands Approval of Ceritinib for ALK-Positive Non-Small Cell Lung CancerThe 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 Approves Pembrolizumab for Tumors with Specific Genetic FeaturesFDA 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 Expands Approval of Pembrolizumab for First-Line Treatment of Non-Small Cell Lung CancerFDA 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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Midostaurin Approved by FDA for Acute Myeloid LeukemiaThe 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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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 CancerThe approval is for patients with recurrent or metastatic head and neck squamous cell carcinoma 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.
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Crizotinib Approval Expanded for Advanced Lung CancerThe 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 LiposarcomaThe 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 CancerThe 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 MyelomaIn November 2015, the FDA approved three new therapies for patients with multiple myeloma.
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Approval of Osimertinib and Necitumumab Increases Lung Cancer Treatment OptionsThe FDA has approved two targeted therapies, osimertinib (Tagrisso™) and necitumumab (Portrazza™), for the treatment of some patients with advanced lung cancer.
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FDA Approves Cobimetinib as Part of Drug Combination for Advanced MelanomaThe FDA has approved the targeted drug cobimetinib, in combination with another targeted therapy, to treat patients with advanced melanoma whose tumors have specific genetic mutations.
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FDA Approves Trabectedin to Treat Two Types of Soft Tissue SarcomaThe FDA has approved trabectedin for patients with advanced liposarcoma and leiomyosarcoma whose cancer has progressed after prior treatment.
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FDA Approves Talimogene Laherparepvec to Treat Metastatic MelanomaThe FDA has approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC). The drug was approved for the treatment of metastatic melanoma that cannot be removed surgically.
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FDA Approves Irinotecan Liposome to Treat Pancreatic CancerPatients with metastatic pancreatic cancer that has progressed after receiving gemcitabine-based chemotherapy now have a new treatment option: irinotecan liposome in combination with fluorouracil and leucovorin.
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FDA Approves Pembrolizumab for Patients with Non-Small Cell Lung CancerThe FDA has approved the drug pembrolizumab to treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors express a protein called PD-L1.
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FDA Approves Nivolumab for Some Melanomas and Lung CancersThe FDA has approved nivolumab in combination with ipilimumab for advanced melanoma and nivolumab alone for advanced nonsquamous lung cancer.
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FDA Approves Combination Drug for Patients with Advanced Colorectal CancerThe FDA has approved a single drug that combines trifluridine and tipiracil to treat patients with metastatic colorectal cancer whose disease progressed after standard treatment.
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FDA Approves Rolapitant to Prevent Nausea and Vomiting from ChemotherapyThe FDA has approved rolapitant to prevent chemotherapy-induced nausea and vomiting.
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FDA Approves Sonidegib for Some Patients with Advanced Basal Cell CarcinomaThe FDA has approved sonidegib for the treatment of patients with locally advanced basal cell carcinoma.
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FDA Approves Expanded Indication for Carfilzomib in Patients with Multiple MyelomaThe FDA has approved carfilzomib in combination with other anticancer drugs to treat patients with relapsed multiple myeloma.
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With FDA Approval, Gefitinib Returns to U.S. Market for Some Patients with Lung CancerThe FDA last month approved gefitinib (Iressa) for the treatment of some patients with lung cancer, marking the drug’s return to the U.S. market after an earlier withdrawal.
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FDA Approves First Therapy for High-Risk NeuroblastomaThe FDA has approved dinutuximab as part of first-line therapy for children with high-risk neuroblastoma.
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FDA Approves First Immunotherapy Treatment for Lung CancerThe FDA has approved nivolumab to treat patients with advanced non-small cell lung cancer that has progressed during or after treatment with platinum-based chemotherapy.
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FDA Approves Panobinostat for Some Patients with Multiple MyelomaThe FDA granted accelerated approval of panobinostat for the treatment of multiple myeloma that has progressed after at least two prior standard therapies.
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FDA Approves Lenvatinib for Radioactive Iodine-Refractory Thyroid CancerThe FDA has approved lenvatinib (Lenvima) to treat some patients with the most common type of thyroid cancer.
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FDA Grants Palbociclib Accelerated Approval for Advanced Breast CancerPalbociclib (Ibrance) is approved to be used in combination with letrozole (Femara) to treat postmenopausal women with metastatic breast cancer.
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A Good Year: FDA Approved Nine New Cancer Drugs in 2014In 2014, the Food and Drug Administration (FDA) approved 41 drugs that had not been approved previously for any indication, the most in nearly 20 years. Of these 41 novel drugs, 9 were approved for the treatment of cancer or cancer-related conditions.