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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Dabrafenib–Trametinib Combination Approved for Solid Tumors with BRAF MutationsFDA 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-3The 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 MyelomaPeople 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 ALLThe 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 CancerAtezolizumab (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.
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Belzutifan Approved to Treat Tumors Linked to Inherited Disorder VHLFDA has approved belzutifan (Welireg) to treat adults with von Hippel-Lindau disease (VHL) who have tumors of the kidney, brain, nervous system, or pancreas. The drug may help these patients avoid or delay surgery by shrinking their tumors.
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FDA Approves Belumosudil to Treat Chronic Graft-Versus-Host DiseaseFDA has approved belumosudil (Rezurock) for the treatment of chronic graft-versus-host disease (GVHD). The approval covers the use of belumosudil for people 12 years and older who have already tried at least two other therapies.
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FDA Approval of Rylaze Will Address Drug Shortage for Childhood ALLFDA has approved a new form of asparaginase called Rylaze. The drug was developed to help alleviate shortages of Erwinia asparaginase, a key part of treatment for children and adults with acute lymphoblastic leukemia.
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FDA Approval of KRAS Inhibitor Sotorasib for Lung Cancer Hailed as MilestoneFDA has approved the first KRAS-blocking drug, sotorasib (Lumakras). The approval, which covers the use of sotorasib to treat some patients with advanced lung cancer, sets the stage for other KRAS inhibitors already in development, researchers said.
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Sacituzumab Govitecan Earns Full Approval for Triple-Negative Breast CancerSacituzumab govitecan (Trodelvy) now has regular FDA approval for people with locally advanced or metastatic triple-negative breast cancer (TNBC). The update follows last year’s accelerated approval of the drug for people with TNBC.
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FDA Approves BCMA-Targeted CAR T-Cell Therapy for Multiple MyelomaThe Food and Drug Administration has approved idecabtagene vicleucel (Abecma) for some people with multiple myeloma. The approval is based, in part, on a small study in which ide-cel partially or completely shrank tumors in 72% of patients.
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Relugolix Approval Expected to Alter Treatment for Advanced Prostate CancerFDA’s recent approval of relugolix (Orgovyx) is expected to affect the treatment of men with advanced prostate cancer. A large clinical trial showed that relugolix was more effective at reducing testosterone levels than another common treatment.
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Cancer “Liquid Biopsy” Blood Test Gets Expanded FDA ApprovalFDA has expanded the approved uses of the FoundationOne Liquid CDx blood test, known as a liquid biopsy, that can help doctors pick specific treatments for some people with cancer. When used in this way, the test is known as a companion diagnostic.
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FDA Approves Blood Tests That Can Help Guide Cancer TreatmentFDA has recently approved two blood tests, known as liquid biopsies, that gather genetic information to help inform treatment decisions for people with cancer. This Cancer Currents story explores how the tests are used and who can get the tests.
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CAR T-Cell Therapy Approved by FDA for Mantle Cell LymphomaA CAR T-cell therapy called brexucabtagene autoleucel (Tecartus) has been approved by the Food and Drug Administration (FDA) for some patients with mantle cell lymphoma. This is the third CAR T-cell therapy approved by FDA for patients with cancer.
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A New FDA Approval Furthers the Role of Genomics in Cancer CareFDA’s approval of pembrolizumab (Keytruda) to treat people whose cancer is tumor mutational burden-high highlights the importance of genomic testing to guide treatment, including for children with cancer, according to NCI Director Dr. Ned Sharpless.
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Selpercatinib Approved for Thyroid and Lung Cancers with RET Gene AlterationsFDA has granted accelerated approval for selpercatinib (Retevmo) to treat certain patients with thyroid cancer or non-small cell lung cancer whose tumors have RET gene alterations. The drug, which works by blocking the activity of RET proteins, was approved based on the results of the LIBRETTO-001 trial.
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With Two FDA Approvals, Prostate Cancer Treatment Enters the PARP EraFDA has approved olaparib (Lynparza) and rucaparib (Rubraca) to treat some men with metastatic prostate cancer. The PARP inhibitors are approved for men whose cancers have stopped responding to hormone treatment and have specific genetic alterations.
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Atezolizumab Plus Bevacizumab Approved to Treat Liver CancerFDA has approved atezolizumab (Tecentriq) plus bevacizumab (Avastin) as an initial treatment for some people with advanced liver cancer. This is the first approval in 13 years for a treatment that is more effective than the current standard, sorafenib.
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Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast CancerFDA has approved sacituzumab govitecan (Trodelvy) for the treatment of triple-negative breast cancer that has spread to other parts of the body. Under the approval, patients must have already undergone at least two prior treatment regimens.