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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Dasatinib Approved by FDA for Some Children with Chronic Myelogenous LeukemiaOn November 9, the FDA approved dasatinib (Sprycel®) for the treatment of children with chronic myelogenous leukemia (CML) whose cancer cells express the Philadelphia chromosome and whose disease is in a relatively early stage, known as the chronic phase.
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Abemaciclib Approved by FDA for Advanced or Metastatic Breast CancerFDA approved abemaciclib (Verzenio™) for the treatment of some people with advanced or metastatic HR-positive, HER2-negative breast cancer whose disease has progressed after treatment with hormone therapy.
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With FDA Approval for Advanced Lymphoma, Second CAR T-Cell Therapy Moves to the ClinicOne month after approving the first CAR T-cell therapy for cancer, FDA has approved a second such therapy. The treatment, axicabtagene ciloleucel (Yescarta™), was approved for some patients with advanced non-Hodgkin lymphoma.
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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.