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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Encorafenib, Cetuximab Combination Approved for Metastatic Colorectal CancerThe Food and Drug Administration has approved encorafenib (Braftovi) in combination with cetuximab (Erbitux) to treat adults with metastatic colorectal cancer whose tumors have a specific mutation in the BRAF gene, called V600E.
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Selumetinib Approved by FDA to Treat Children with NF1The Food and Drug Administration (FDA) has approved selumetinib (Koselugo) to treat children with neurofibromatosis 1 (NF1), a genetic disorder that causes tumors, called plexiform neurofibromas, to form throughout the nervous system.
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Avapritinib Approved to Treat GIST with a Rare Gene AlterationAvapritinib (Ayvakit) has been approved for adults with gastrointestinal stromal tumors (GIST) whose tumors have an alteration in a portion of the PDGFRA gene called exon 18. The approval applies to those whose tumors cannot be removed with surgery or have spread.
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Enfortumab Vedotin Approved for Recurrent Bladder CancerEnfortumab vedotin-ejfv (Padcev) has been approved for people with advanced bladder cancer. FDA granted the drug accelerated approval for cancers that have progressed despite previous treatments.
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For Metastatic HER2-Positive Breast Cancer, New Treatments EmergeTucatinib improved survival for women in the HER2CLIMB trial, including some whose cancer had spread to the brain. Trastuzumab deruxtecan improved survival and shrank many tumors in the DESTINY-Breast01 trial, which led to its accelerated approval.
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FDA Approves Entrectinib Based on Tumor Genetics Rather Than Cancer TypeFDA has approved entrectinib (Rozlytrek) for the treatment of children and adults with tumors bearing an NTRK gene fusion. The approval also covers adults with non-small cell lung cancer harboring a ROS1 gene fusion.
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Pembrolizumab Approved for Some Patients with Advanced Esophageal CancerFDA has approved the immunotherapy drug pembrolizumab (Keytruda) to treat some patients with advanced esophageal cancer. Patients must have certain levels of the protein PD-L1 on their tumors, as determined by an FDA-approved test.
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Combination Therapy with Venetoclax Approved for Chronic Lymphocytic LeukemiaThe Food and Drug Administration has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the initial treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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T-DM1 Approval Expanded to Include Some Women with Early-Stage HER2-Positive Breast CancerFDA has expanded the approved use of the drug ado-trastuzumab emtansine (Kadcyla), also called T-DM1, to include adjuvant treatment in some women with early-stage HER2-positive breast cancer.
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Atezolizumab Approved for Some Patients with Triple-Negative Breast CancerFDA has approved atezolizumab (Tecentriq) in combination with chemotherapy for the treatment of some women with advanced triple-negative breast cancer. This is the first FDA-approved regimen for breast cancer to include immunotherapy.
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Pembrolizumab Now Second Immunotherapy Approved to Treat Merkel Cell CarcinomaFDA has approved pembrolizumab (Keytruda) to treat people with Merkel cell carcinoma, a rare and deadly form of skin cancer. The approval covers use of the drug to treat locally advanced or metastatic forms of the disease.
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Atezolizumab Approved for Initial Treatment of Metastatic Lung CancerOn December 6, 2018, the Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with a standard three-drug regimen as an initial treatment for advanced lung cancer that does not have EGFR or ALK mutations.
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FDA Approvals Bring New Options for Older Patients with AMLFDA has approved venetoclax (Venclexta) and glasdegib (Daurismo) for use in people with acute myeloid leukemia aged 75 and older and those with health conditions that prevent them from receiving the intensive chemotherapy regimen that is the standard initial treatment.
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Immunotherapy Drug Cemiplimab Approved for Advanced Squamous Cell Skin CancerThe Food and Drug Administration approved the immunotherapy drug cemiplimab (Libtayo) for an advanced form of cutaneous squamous cell carcinoma (SCC), a common type of skin cancer. It is the first agent to be approved specifically for advanced SCC.
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Moxetumomab Approved by FDA for Hairy Cell LeukemiaThe FDA has approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). Moxetumomab is approved to treat patients with HCL who have already undergone at least two lines of standard treatments.
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Ribociclib Approval Expanded for Some Women with Advanced Breast CancerFDA has expanded the approved uses of ribociclib (Kisqali) for women with advanced breast cancer, including new uses in pre- and postmenopausal women. It’s the first approval under a new FDA program to speed the review of cancer drugs.
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Targeted Drug Approved for Acute Myeloid Leukemia with IDH1 Gene MutationsThe FDA has approved ivosidenib (Tibsovo) for the treatment of adults with acute myeloid leukemia (AML) that has a specific mutation in a gene called IDH1. Ivosidenib becomes the first FDA-approved IDH1-targeted treatment.
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Combination of Immunotherapy Drugs Approved for Metastatic Colorectal CancerThe FDA has approved the combination of the immune checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo) for the treatment of patients with metastatic colorectal cancer whose tumor cells have defects that affect their ability to repair DNA.
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New Immunotherapy Option Approved for Cervical Cancer, Rare LymphomaFDA has approved pembrolizumab (Keytruda) for some women with advanced cervical cancer and some patients with primary mediastinal large B-cell lymphoma (PMBCL), a rare type of non-Hodgkin lymphoma.
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FDA Alters Approved Use of Two Checkpoint Inhibitors for Bladder CancerFDA has changed the approved uses of the immunotherapy drugs pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to treat the most common form of bladder cancer. The change is based on whether patients’ tumors have a specific biomarker.