{"id":969,"date":"2026-08-26T20:43:36","date_gmt":"2026-08-26T20:43:36","guid":{"rendered":"https:\/\/noimfine.com\/sph06\/?p=969"},"modified":"2026-09-26T20:49:01","modified_gmt":"2026-09-26T20:49:01","slug":"inqovi-fda-approves-first-all-oral-regimen-for-certain-patients-with-newly-diagnosed-acute-myeloid-leukemia-2","status":"publish","type":"post","link":"https:\/\/noimfine.com\/sph06\/2026\/08\/26\/inqovi-fda-approves-first-all-oral-regimen-for-certain-patients-with-newly-diagnosed-acute-myeloid-leukemia-2\/","title":{"rendered":"Inqovi: FDA Approves First All\u2011Oral Regimen for Certain Patients With Newly Diagnosed Acute Myeloid Leukemia"},"content":{"rendered":"<div><!--[--><!--&gt;--><\/p>\n<div>\n<div>\n<div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<div>\n<section><a href=\"https:\/\/www.webmd.com\/drugs\/inqovi-decitabine-cedazuridine\">Inqovi<\/a> is a fixed\u2011dose oral pill that contains two medicines, decitabine and cedazuridine.The FDA has approved using Inqovi along with another oral pill, venetoclax, for treating newly diagnosed acute myeloid leukemia (AML) in adults who are 75 or older or who are considered unfit for intensive induction chemotherapy.AML is a fast-growing cancer of the blood and bone marrow, which most often occurs in older adults, with an average age at diagnosis of around 69.About 22,720 people in the U.S.<iframe src=\"https:\/\/www.youtube.com\/embed\/KZ-poa6dfmU\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>are expected to be diagnosed with AML in 2026, and more than half may not be able to receive intensive induction chemotherapy because of age or other health issues.The two medicines in Inqovi work together to destroy cancer cells.Decitabine is a type of chemotherapy that helps your bone marrow make normal blood cells while also helping to kill abnormal blood cells.<iframe src=\"https:\/\/www.youtube.com\/embed\/jMTfKIg3B2A\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>Cedazuridine keeps the levels of decitabine in your body higher for longer by blocking the enzyme that breaks it down.<iframe src=\"https:\/\/www.youtube.com\/embed\/CKEyCSdmb-s\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>This combination of oral medications aims to match the exposure seen with intravenous (IV) decitabine.<\/section>\n<section>First approved in 2020, Inqovi was already cleared for certain bone marrow disorders, including myelodysplastic syndromes and chronic myelomonocytic leukemia.<iframe src=\"https:\/\/www.youtube.com\/embed\/xt5emaghnY4\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>When used for AML, it is combined with another medicine, venetoclax, which blocks BCL-2, a protein that helps cancer cells survive. Venetoclax helps to restore the normal cell death process (apoptosis), causing cancer cells to self-destruct. Inqovi plus venetoclax is now the only fully oral combination approved for this group of patients. This may allow you to begin treatment at home instead of starting with a hospital\u2011based intensive regimen.<\/section>\n<\/div>\n<div>\n<section>\n<h2>Why Was It Approved?<\/h2>\n<p>The FDA\u2019s decision was based on data from a clinical trial where Inqovi combined with venetoclax resulted in remission in many patients. The effectiveness of Inqovi tablets combined with venetoclax was evaluated in a study involving 101 adults with newly diagnosed AML who were at least 75 years old or not eligible for intensive chemotherapy due to other health conditions. Among them, 42% achieved complete remission (CR), with an average time to response of two months. The median duration of CR was not reached, meaning many patients were still benefiting from treatment after an average of 9 months of follow-up.<\/section>\n<section>When Inqovi was used with venetoclax for AML, very low blood cell counts were common and potentially life\u2011threatening. This included new or worsening low platelet counts that led to bleeding, as well as low white blood cells that led to serious infections, including pneumonia and sepsis. Other commonly observed side effects included gastrointestinal symptoms, nausea, decreased appetite, fatigue, mouth sores, swelling, shortness of breath, rash, muscle pain, heart rhythm changes, and abdominal pain.<\/section>\n<section>\n<h2>What Do I Need to Know?<\/h2>\n<p>You will take one Inqovi tablet by mouth once daily on days 1 through 5 of each 28\u2011day cycle. Take Inqovi on an empty stomach at least two hours before or two hours after eating. Venetoclax is taken once daily with a meal on every day of the 28-day cycle. Separate Inqovi and venetoclax doses by at least two hours. You will continue your treatment cycles until your disease worsens or side effects warrant a change. Your health care provider will check complete blood counts before you start treatment, before each new cycle, and as needed. They may use growth factors and anti\u2011infective medicines to treat or help prevent infections. Your next cycle may be delayed or restarted at the same dose or a lower dose based on your blood counts and how you are doing.<\/section>\n<section>Very low blood counts and serious infections can occur during treatment. Call your health care provider right away if you develop a fever or notice signs of infection, unusual bruising or bleeding, or severe fatigue. Inqovi can harm a fetus. If you can become pregnant, use birth control during treatment and for six months after the last dose. If you are male and have a partner who can become pregnant, use birth control during treatment and for three months after the last dose. Do not breastfeed during treatment and for two weeks after the last dose. Cedazuridine blocks an enzyme that breaks down certain medicines, so using Inqovi with those medicines can raise their levels and increase side effects; therefore, such combinations should generally be avoided. Tell your health care provider about all prescription medicines, over-the-counter medicines, vitamins, and herbal supplements you take.<\/section>\n<\/div>\n<\/div>\n<p><!--&gt;<\/div>\n\n\n--><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Inqovi is a fixed\u2011dose oral pill that contains two medicines, decitabine and cedazuridine.The FDA has approved using Inqovi along with another oral pill, venetoclax, for treating newly diagnosed acute myeloid leukemia (AML) in adults who are 75 or older or&#8230; <\/p>\n","protected":false},"author":2,"featured_media":320,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/969","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/comments?post=969"}],"version-history":[{"count":1,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/969\/revisions"}],"predecessor-version":[{"id":977,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/969\/revisions\/977"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media\/320"}],"wp:attachment":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media?parent=969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/categories?post=969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/tags?post=969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}