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 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 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 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 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 (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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The 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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FDA’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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FDA 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 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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A 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.