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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Colorectal Cancer Screening: Where Does the Shield Liquid Biopsy Fit In?FDA recently approved the Shield test, the first blood test for the primary screening of people at average risk of colorectal cancer. Where does it fit in with other screening options for the disease, including colonoscopy and stool tests?
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FDA Approves Engineered Cell Therapy for Advanced Synovial SarcomaFDA approved afami-cel (Tecelra) to treat metastatic synovial sarcoma, a type of soft tissue sarcoma. The approval is for patients who have already received chemo and whose tumors are positive for MAGE-A4. Afami-cel is the first T-cell receptor therapy approved for cancer.
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More Immunotherapy Options Approved for Treating Endometrial CancerPeople with advanced endometrial cancer now have new FDA-approved treatment options: pembrolizumab and durvalumab, paired with chemotherapy, for tumors with a genetic change called mismatch repair deficiency. The agency also expanded the approved uses of dostarlimab for the disease.
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Tovorafenib Approved for Some Children with Low-Grade GliomaFDA has granted an accelerated approval to tovorafenib (Ojemda) for kids and teens who have low-grade glioma with changes in the BRAF gene. In a small clinical trial, the drug shrank or completely eliminated tumors in nearly 70% of patients.
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Alectinib Approved as an Adjuvant Treatment for Lung CancerFDA has approved alectinib (Alecensa) as adjuvant therapy for people with lung cancer who have ALK-positive tumors. In a clinical trial, alectinib helped people live longer after surgery without their cancer returning than chemotherapy.
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FDA Approves Trastuzumab Deruxtecan for Any HER2-Positive Solid CancerTrastuzumab deruxtecan (Enhertu) can now be used to treat any advanced solid cancer that produces high levels of the protein HER2 (HER2-positive tumors). FDA’s accelerated approval was based on findings from three clinical trials.
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Approval of Elahere Expands Treatment Options for Some Advanced Ovarian CancersFDA approved mirvetuximab soravtansine-gynx (Elahere) to treat people with advanced, platinum-resistant ovarian cancer whose tumors overproduce a protein called FR-α. The full approval was based on the results of a large, randomized trial called MIRASOL, which showed Elahere improved survival for these people.
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First Cancer TIL Therapy Gets FDA Approval for Advanced MelanomaIn an event more than three decades in the making, FDA has approved lifileucel (Amtagvi), the first cancer treatment that uses immune cells called tumor-infiltrating lymphocytes, or TILs.
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Repotrectinib Expands Treatment Options for Lung Cancers with ROS1 FusionsThe results of the clinical trial that led to FDA’s 2023 approval of repotrectinib (Augtyro) for lung cancers with ROS1 fusions have been published. The drug shrank tumors in 80% of people receiving the drug as an initial treatment.
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Enzalutamide Gets Added Approval for Prostate Cancer That Hasn’t SpreadUnder a new FDA approval, enzalutamide (Xtandi) can now be used alone, or in combination with leuprolide, to treat people with nonmetastatic prostate cancer that is at high risk of returning after surgery or radiation.
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Toripalimab Becomes First Immunotherapy Drug Approved for Nasopharyngeal CancerFDA approved toripalimab (Loqtorzi) based on the results of a large clinical trial showing that, when added to chemotherapy, the drug extended survival in people with nasopharyngeal cancer that returned after initial treatment or spread in the body.
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FDA Amends Approval of Pembrolizumab to Treat Stomach and Esophageal Junction CancerFDA has changed its 2021 approval of pembrolizumab (Keytruda) along with trastuzumab (Herceptin) and chemotherapy for treating HER2-positive stomach or GEJ cancer. The agency also announced a new approval of pembrolizumab for HER2-negative forms of these same cancers.
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Quizartinib Approval Adds New Treatment Option for AML, Including in Older PatientsTreatment options for people with acute myeloid leukemia (AML) have expanded yet again. On July 20, FDA approved quizartinib (Vanflyta) combined with chemotherapy as a first-line treatment for AML with a specific change in the FLT3 gene.
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FDA Approves New Initial Treatment Option for Some Metastatic Prostate CancersFDA approved enzalutamide (Xtandi) combined with talazoparib (Talzenna) for metastatic castration-resistant prostate cancer with alterations in any of 12 DNA repair genes. The drug combination, which blocks both DNA repair activities and hormones that fuel cancer growth, was more effective than the standard treatment in a large clinical trial.
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Tucatinib and Trastuzumab Combination Approved for Advanced Colorectal CancerFDA approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drug combination.
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Zanubrutinib’s Approval Improves Targeted Treatment for CLLFDA has approved zanubrutinib (Brukinsa) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on results from two clinical trials. In both trials, the drug, which blocks a protein called BTK, was more effective and caused fewer side effects than other treatments.
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Trial Suggests Expanded Role for Blinatumomab in Treating ALLThe immunotherapy drug blinatumomab (Blincyto) extends life for people with acute lymphoblastic leukemia who are in remission, even those with no signs of disease after initial treatment, a trial has found.
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Brentuximab Approved for High-Risk Hodgkin Lymphoma in Children and AdolescentsBased on an NCI-sponsored clinical trial conducted by the Children’s Oncology Group, FDA has approved the drug brentuximab vedotin (Adcetris) in combination with chemotherapy for some children and adolescents with Hodgkin lymphoma.
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Sodium Thiosulfate Approved to Reduce Chemo-Related Hearing Loss in Children with CancerThe chemotherapy cisplatin often causes permanent hearing loss. Sodium thiosulfate (Pedmark) is the first treatment approved by FDA that can reduce the risk of hearing loss and the severity of damage to the inner ear in children treated with cisplatin.
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Enhertu Marks First Targeted Therapy for HER2-Mutant Lung CancerOn August 11, the Food and Drug Administration (FDA) gave accelerated approval to trastuzumab deruxtecan (Enhertu) for adults with non-small cell lung cancer (NSCLC) that has a specific mutation in the HER2 gene. Around 3% of people with NSCLC have this kind of HER2 mutation.