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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Alectinib Approved as an Adjuvant Treatment for Lung Cancer
FDA 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 Cancer
Trastuzumab 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 Cancers
FDA 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 Melanoma
In 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 Fusions
The 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 Spread
Under 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 Cancer
FDA 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 Cancer
FDA 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 Patients
Treatment 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 Cancers
FDA 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 Cancer
FDA 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 CLL
FDA 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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Brentuximab Approved for High-Risk Hodgkin Lymphoma in Children and Adolescents
Based 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 Cancer
The 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 Cancer
On 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.
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Dabrafenib–Trametinib Combination Approved for Solid Tumors with BRAF Mutations
FDA has approved the combination of the targeted drugs dabrafenib (Tafinlar) and trametinib (Mekinist) for nearly any type of advanced solid tumor with a specific mutation in the BRAF gene. Data from the NCI-MATCH trial informed the approval.
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Opdualag Becomes First FDA-Approved Immunotherapy to Target LAG-3
The immunotherapy treatment, which combines the LAG-3 inhibitor relatlimab and PD-1 inhibitor nivolumab, becomes the first new immune checkpoint inhibitor approved in 8 years. Both drugs are given to patients via a single infusion to treat advanced melanoma.
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Carvykti Approval Marks Second CAR T-Cell Therapy for Multiple Myeloma
People with advanced multiple myeloma now have another option for CAR T-cell therapy with the recent approval of ciltacabtagene autoleucel (Carvykti). Like the first approved CAR T-cell therapy, Carvykti targets the BCMA protein on myeloma cells.
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Tecartus Becomes First CAR T-Cell Therapy Approved for Adults with ALL
The CAR T-cell therapy Tecartus has become the first such treatment approved by FDA to treat adults with acute lymphoblastic leukemia (ALL). The approval is for patients whose cancer has not responded to treatment or returned after treatment.
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Adjuvant Immunotherapy Approved for Some Patients with Lung Cancer
Atezolizumab (Tecentriq) is now the first immunotherapy approved by FDA for use as an additional, or adjuvant, treatment for some patients with non-small cell lung cancer. The approval was based on results of a clinical trial called IMpower010.