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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Approval Expanded for Venetoclax in Chronic Lymphocytic LeukemiaFDA expanded the approval of venetoclax (Venclexta) for people with chronic lymphocytic leukemia (CLL) to include those whose cancer has progressed after previous treatment, regardless of whether their cancer cells have the deletion 17p gene alteration.
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Dabrafenib–Trametinib Combination Approved for Melanoma, Anaplastic Thyroid CancerFDA recently approved the targeted-drug combination to treat patients with advanced melanoma and a subset of patients with a rare and aggressive form of thyroid cancer whose tumors have a specific mutation in the BRAF gene.
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FDA Approves Second CAR T-Cell Therapy for LymphomaFDA has approved tisagenlecleucel (Kymriah) for certain kinds of non-Hodgkin lymphoma. Read about the trial that led to the approval and what the approval means for people with lymphoma.
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FDA Approves Nivolumab and Ipilimumab Combination for Advanced Kidney CancerFDA has approved the combination of two immunotherapy drugs, nivolumab (Opdivo) and ipilimumab (Yervoy), as an initial treatment for some patients with advanced kidney cancer. Learn how this approval will affect patient care.
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Rucaparib Approved as Maintenance Treatment for Some Recurrent Ovarian CancersFDA has expanded its approval of rucaparib (Rubraca) as a maintenance therapy for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer whose tumors shrank after subsequent treatment with a platinum-based chemotherapy.
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Brentuximab Approved for Initial Treatment of Advanced Hodgkin LymphomaThe FDA has expanded the approved uses of brentuximab (Adcetris) in people with Hodgkin lymphoma. Under the new approval, brentuximab can be used in combination with three other chemotherapy drugs as an initial treatment in patients with advanced disease.
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Abemaciclib Approval Expands Initial Treatment Options for Advanced Breast CancerFDA has approved the CDK4/6 inhibitor abemaciclib (Verzenio) as a first-line treatment in some women with advanced or metastatic breast cancer. Under the approval, the drug must be used in combination with an aromatase inhibitor.
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FDA Approves Apalutamide for Some Men with Prostate CancerIn the trial that led to the approval, apalutamide (Erleada) delayed cancer metastasis for men with prostate cancer that is resistant to androgen deprivation therapy.
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Cabozantinib Approval Expands Initial Treatment Options for Advanced Kidney CancerThe Food and Drug Administration has approved cabozantinib (Cabometyx®) as an initial treatment for patients with advanced renal cell carcinoma, the most common type of kidney cancer.
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Abiraterone Approved for Earlier Use in Men with Metastatic Prostate CancerThe Food and Drug Administration (FDA) has expanded the approval of abiraterone (Zytiga®) for men with prostate cancer. The agency approved abiraterone, in combination with the steroid prednisone, for men with metastatic prostate cancer that is responsive to hormone-blocking treatments (also known as castration-sensitive) and is at high risk of progressing.
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FDA Approves New Treatment for Certain Neuroendocrine TumorsPeople with cancerous neuroendocrine tumors (NETs) that affect the digestive tract now have a new treatment option. On January 29, FDA approved the targeted treatment lutetium Lu 177 dotatate (Lutathera®) for adult patients with advanced NETs that affect the pancreas or gastrointestinal tract.
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Olaparib Approved for Treating Some Breast Cancers with BRCA Gene MutationsThe drug olaparib (Lynparza®) is the first treatment approved by the Food and Drug Administration for patients with metastatic breast cancer who have inherited mutations in the BRCA1 or BRCA2 genes.
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Nilotinib Can Be Discontinued in Some Patients with Chronic Myelogenous LeukemiaOn December 22, FDA approved an update to the label of nilotinib (Tasignia) that states that some patients with CML who are taking nilotinib and whose cancer has been in remission for an extended period can safely stop taking it.
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Genomic Profiling Tests Cleared by FDA Can Help Guide Cancer Treatment, Clinical Trial EnrollmentThe FDA has recently approved two tests to identify genetic alterations in tumors. One of the tests can be used to identify patients who may be candidates to receive specific targeted therapies.
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Brentuximab Vedotin Approved for Two Rare LymphomasFDA has approved brentuximab vedotin (Adcetris®) for the treatment of adults who have been treated previously for either primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides, two rare lymphomas that start as rashes on the skin.
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Acalabrutinib Receives FDA Approval for Mantle Cell LymphomaThe FDA has granted accelerated approval to acalabrutinib (Calquence®) for the treatment of adults with mantle cell lymphoma whose cancer has progressed after receiving at least one prior therapy.
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FDA Approves Alectinib For Initial Treatment of ALK-Positive Lung CancerFDA has approved alectinib (Alecensa) as a first-line treatment option for patients with advanced non-small cell lung cancer that is ALK positive. Alectinib is the third ALK inhibitor to be approved in this setting.
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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.