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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The 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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FDA 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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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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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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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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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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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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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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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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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.