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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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.