{"id":1009,"date":"2026-08-27T22:52:53","date_gmt":"2026-08-27T22:52:53","guid":{"rendered":"https:\/\/noimfine.com\/sph06\/?p=1009"},"modified":"2026-09-27T22:54:24","modified_gmt":"2026-09-27T22:54:24","slug":"fda-approves-darzalex-faspro-as-part-of-a-new-first-line-quadruplet-regimen-for-multiple-myeloma-2","status":"publish","type":"post","link":"https:\/\/noimfine.com\/sph06\/2026\/08\/27\/fda-approves-darzalex-faspro-as-part-of-a-new-first-line-quadruplet-regimen-for-multiple-myeloma-2\/","title":{"rendered":"FDA Approves Darzalex Faspro as Part of a New First-Line Quadruplet Regimen for Multiple Myeloma"},"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\/darzalex-faspro-daratumumab-hyaluronidase\">Darzalex Faspro<\/a> is an injectable medicine used to treat adults with multiple myeloma, a type of blood cancer, and light chain (AL) amyloidosis, a rare condition caused by the buildup of abnormal proteins in organs.<iframe src=\"https:\/\/www.youtube.com\/embed\/a9MDfJmmYCw\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>The FDA has now approved Darzalex Faspro for use in combination with\u00a0<a href=\"https:\/\/www.webmd.com\/drugs\/bortezomib-velcade\">bortezomib<\/a>,\u00a0<a href=\"https:\/\/www.webmd.com\/drugs\/lenalidomide-revlimid\">lenalidomide<\/a>, and\u00a0<a href=\"https:\/\/www.webmd.com\/drugs\/dexamethasone-decadron\">dexamethasone<\/a> (the D-VRd regimen), for adults with newly diagnosed multiple myeloma who are unable to receive a stem cell transplant.<iframe src=\"https:\/\/www.youtube.com\/embed\/DnflkpzZxWM\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>Multiple myeloma is a blood cancer in which abnormal plasma cells (a type of white blood cell found in the bone marrow) multiply and crowd out healthy blood-forming cells.<iframe src=\"https:\/\/www.youtube.com\/embed\/7maxX41R_yA\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>It is the second most common blood cancer worldwide and has no cure. In 2026, it is expected that about 36,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people will die due to this disease. While some patients don\u2019t show any symptoms initially, most are diagnosed after developing problems such as bone pain or fractures, anemia, fatigue, high calcium levels, kidney issues, or frequent infections. The five-year survival rate is about 60%.<\/section>\n<section>In the quadruplet D-VRd regimen, Darzalex Faspro is given as a shot under the skin and combines two ingredients: daratumumab and hyaluronidase. Daratumumab is a lab-made antibody that works by targeting a special protein called CD38 on myeloma cells, helping your immune system identify, locate, and destroy abnormal blood cells, while hyaluronidase works by speeding up and improving the absorption of the medicine. Bortezomib disrupts the protein disposal system in the tumor cells, causing buildup of toxic substances that leads to cell death. Lenalidomide helps the immune system to identify and kill cancer cells and also interferes with signals promoting myeloma cell growth. Dexamethasone is a corticosteroid that reduces inflammation, supports cancer cell death, improves anticancer effects of other drugs, and helps manage treatment-related reactions. <a>Initially approved in 2020, Darzalex Faspro has several uses, including among patients with newly diagnosed multiple myeloma\u00a0<\/a>(regardless of their eligibility for a stem cell transplant), relapsed or hard-to-treat multiple myeloma, high-risk smoldering multiple myeloma, or AL amyloidosis. This approval matters because this quadruplet regimen is especially helpful for older adults or those with other health problems that make transplant too risky.<\/section>\n<\/div>\n<div>\n<section>\n<h2>Why Was It Approved?<\/h2>\n<p>The FDA\u2019s approval of Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (VRd) was based on a clinical study that showed that this combination therapy was safe and effective and produced stronger and longer-lasting treatment responses, higher rates of no detectable cancer, and a reduced risk for disease progression or death compared with the VRd-only regimen\u00a0in adults with newly diagnosed multiple myeloma who were either ineligible or did not opt for stem cell transplant. In the phase 3 study, a total of 395 patients were randomly assigned to receive either the D-VRd or standard VRd regimen. The results showed that 52.3% of patients receiving D-VRd vs 34.8% receiving VRd alone achieved minimal residual disease (MRD) negativity (meaning no detectable cancer cells were found using highly sensitive testing) at a median follow-up of 22 months. At a median follow-up of 39 months, D-VRd nearly doubled the rate of sustained MRD negativity lasting at least 12 months compared to that with VRd alone (42.6% vs. 25.3%) and reduced the risk for disease progression or death by 40%.<\/section>\n<section>After nearly five years of follow-up, complete response or better was achieved in 81.2% of patients treated with D-VRd vs 61.6% treated with VRd. Overall survival data were not mature at the time. The safety profile of D-VRd was consistent with the known side effects of the individual medicines, with the most common adverse events including upper respiratory infections, nerve-related symptoms such as numbness or tingling, muscle and joint pain, diarrhea, tiredness, swelling, skin rashes, movement or coordination problems, dizziness, increased susceptibility to COVID-19 infection, nausea, constipation, abdominal pain, sleep problems, fever, cough, kidney-related issues, and urinary tract infection.<\/section>\n<section>\n<h2>What Do I Need to Know?<\/h2>\n<p>Darzalex Faspro is given as a quick injection under the skin, usually in the abdomen area, by your health care provider. Each dose takes about three to five minutes. In the D\u2011VRd regimen, treatment for newly diagnosed multiple myeloma starts with a weekly injection of Darzalex\u202fFaspro for the first six weeks, followed by an injection once every three weeks until week 24, and then once a month after that. This can continue until your disease progresses or side effects are no longer tolerable.<\/section>\n<\/div>\n<div>\n<section>Before and after each dose, your health care provider will give you other medicines like steroids, antihistamines, and acetaminophen to help lower the risk for allergic reactions. Your health care provider will determine the exact schedule and dosing for the other medicines based on their respective prescribing information and the treatment plan. This medicine can affect results of blood tests used to match blood groups\/types. If you ever need a blood transfusion, make sure your health care provider and the blood bank know that you\u2019ve received Darzalex Faspro. Be sure to inform your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, to avoid potential interactions. You should not take Darzalex Faspro if you\u2019ve had a serious allergic reaction to daratumumab, hyaluronidase, or any of the ingredients in the medicine. Before starting treatment, tell your health care provider about your medical history, especially if you have or have had breathing problems, shingles, or hepatitis B infection. The medicine can reactivate hepatitis B, so your health care provider will check you before, during, and after treatment.<\/section>\n<section>Darzalex Faspro can lower your blood cell counts, which may increase your risk for infections or bleeding. Your health care provider will check your blood regularly and watch for signs of infection or heart problems. Some infections linked to this medicine can be life-threatening. If you could become pregnant, you should use birth control while taking this medicine and for three months after your last dose. Darzalex Faspro may harm a fetus. If you are pregnant or planning to become pregnant or breastfeeding, talk to your provider before starting treatment. Contact your health care provider right away if you feel very tired or notice dark urine; yellowing of your skin or the whites of your eyes; any signs of infection such as fever, trouble breathing, <a>or pain while urinating<\/a>; unusual bleeding or bruising; or signs of an allergic reaction such as breathing problems, wheezing, dizziness, runny or stuffy nose, eye or vision problems, or a rapid heartbeat. These could be signs of serious side effects.<\/section>\n<\/div>\n<\/div>\n<p><!--&gt;<\/div>\n\n\n--><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Darzalex Faspro is an injectable medicine used to treat adults with multiple myeloma, a type of blood cancer, and light chain (AL) amyloidosis, a rare condition caused by the buildup of abnormal proteins in organs. The FDA has now approved&#8230; <\/p>\n","protected":false},"author":2,"featured_media":515,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1009","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\/1009","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=1009"}],"version-history":[{"count":1,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/1009\/revisions"}],"predecessor-version":[{"id":1017,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/1009\/revisions\/1017"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media\/515"}],"wp:attachment":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media?parent=1009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/categories?post=1009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/tags?post=1009"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}