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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FDA Approves Apalutamide for Some Men with Prostate Cancer
In 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 Cancer
The 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 Cancer
The 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 Tumors
People 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 Mutations
The 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 Leukemia
On 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 Enrollment
The 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 Lymphomas
FDA 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 Lymphoma
The 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 Cancer
FDA 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 Leukemia
On 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 Cancer
FDA 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 Clinic
One 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 Cancer
The 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 Lymphoma
FDA 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 Cancer
The 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 Leukemia
FDA 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 Cancer
FDA 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 Leukemia
FDA 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 Cancer
FDA 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.