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 the combination of the immunotherapy drugs ipilimumab (Yervoy) and nivolumab (Opdivo) for the initial treatment of people with advanced colorectal cancer whose tumors are classified as MSI-H or dMMR.
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FDA has approved zenocutuzumab (Bizengri) to treat people with pancreatic or non-small cell lung cancer whose tumors have a rare genetic alteration called an NRG1 fusion. The approval is based on a clinical trial in which the drug shrank tumors in a third of patients.
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The injectable form of nivolumab, called Opdivo Qvantig, is quicker and easier to give, several oncologists said, and is just as effective as the intravenous form. Injectable forms of other immunotherapies are also on the horizon.
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FDA’s approvals of Darzalex Faspro and Sarclisa, each used in combination with standard three-drug treatment regimens, should change the initial treatment of newly diagnosed multiple myeloma, including for patients who can’t get a stem cell transplant.
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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 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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People 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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FDA 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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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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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.