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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Nivolumab Receives Accelerated Approval from FDA for Advanced Liver CancerThe FDA has granted accelerated approval to the immunotherapy drug nivolumab (Opdivo®) for patients with advanced liver cancer who have previously been treated with the targeted therapy sorafenib (Nexavar®).
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Copanlisib Approved for Follicular LymphomaFDA has granted accelerated approval to copanlisib (Aliqopa®) for the treatment of patients with follicular lymphoma, a form of non-Hodgkin lymphoma.
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Pembrolizumab Secures FDA Approval in Stomach CancerThe FDA has granted accelerated approval to the immunotherapy drug pembrolizumab (Keytruda®) for use in patients with advanced gastric (stomach) cancer that is PD-L1 positive.
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Gemtuzumab Receives New FDA Approval for Acute Myeloid LeukemiaFDA has approved gemtuzumab ozogamicin (Mylotarg™) for adults with newly diagnosed CD33-positive AML and patients 2 years and older with CD33-positive AML who have experienced a relapse or whose disease has not responded to initial treatment.
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FDA Expands Approval of Fulvestrant for Advanced Breast CancerFDA has expanded its approval of fulvestrant (Faslodex®) as a standalone treatment for postmenopausal women with advanced HR-positive, HER2-negative breast cancer who have not previously undergone endocrine therapy.
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FDA Approves Inotuzumab for Adults with B-Cell Acute Lymphoblastic LeukemiaFDA has approved inotuzumab (Besponsa®) for some adults with B-cell acute lymphoblastic leukemia (ALL). The approval covers patients with B-cell ALL whose disease has relapsed or is refractory to standard chemotherapy.
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FDA Approves Olaparib as Maintenance Therapy for Recurrent Ovarian CancerFDA has granted regular approval to olaparib tablets (Lynparza®) as maintenance treatment for patients with recurrent ovarian cancer who are having partial or complete responses to platinum-based chemotherapy.
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CAR T-Cell Therapy Approved for Some Children and Young Adults with LeukemiaFDA has approved tisagenlecleucel (Kymriah™), a type of immunotherapy called CAR T-cell therapy, for some children and young adults with advanced acute lymphoblastic leukemia (ALL).
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Two New Therapies Approved for Acute Myeloid LeukemiaFDA has approved two new treatments for some adult patients with acute myeloid leukemia (AML): enasidenib (Idhifa®), which targets the IDH2 protein; and liposomal cytarabine-daunorubicin CPX-351 (Vyxeos®), a two-drug chemotherapy combination encapsulated in liposomes.
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Neratinib Approved by FDA for HER2-Positive Breast CancerFDA has approved neratinib for patients with early-stage HER2-positive breast cancer who have finished at least 1 year of adjuvant therapy with trastuzumab.
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FDA Approves Nivolumab for Some Metastatic Colorectal CancersFDA has granted accelerated approval to the immunotherapy drug nivolumab (Opdivo®) for patients with metastatic colorectal cancer whose tumors have alterations that affect DNA repair.
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Ibrutinib Becomes First FDA-Approved Drug for Chronic Graft-Versus-Host DiseaseA drug used to treat several blood cancers, ibrutinib, has been approved by FDA to treat chronic graft-versus-host disease, making it the first approved therapy for this potentially fatal side effect of cancer-related stem cell transplants.
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FDA Grants Full Approval to Blinatumomab for Acute Lymphoblastic LeukemiaFDA changed its accelerated approval of blinatumomab (Blincyto) for some patients with acute lymphoblastic leukemia to a full approval and expanded the approved indications for its use.
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FDA Clears Wider Use of Cooling Cap to Reduce Hair Loss during ChemotherapyThe FDA has cleared a cooling cap—a device designed to reduce hair loss during chemotherapy called the DigniCap Scalp Cooling System—for use by patients with any type of solid tumor.
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Two-Drug Combination Approved for Lung Cancers with BRAF MutationsFDA approved the combination of dabrafenib (Tafinlar®) and trametinib (Mekinist®) for the treatment of metastatic non-small cell lung cancer (NSCLC) that has an alteration in the BRAF gene called the V600E mutation.
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New Rituximab Formulation Approved for Some Lymphomas, LeukemiaThe 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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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.