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 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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The 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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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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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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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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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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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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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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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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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.