{"id":14893,"date":"2026-06-02T20:49:00","date_gmt":"2026-06-02T18:49:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=0feac09ed4e955b718e90c6d9715bd1e"},"modified":"2026-06-02T20:49:00","modified_gmt":"2026-06-02T18:49:00","slug":"cavhanza-nilotinib-orally-disintegrating-tablets-a-new-fda-approved-treatment-offering-ppi-and-h2ra-flexibility-for-ph-cml-patients1","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=14893","title":{"rendered":"CAVHANZA\u2122 (nilotinib) Orally Disintegrating Tablets: A New, FDA-approved Treatment Offering PPI and H2RA Flexibility for Ph+ CML Patients1"},"content":{"rendered":"<p>CAMBRIDGE, England--(BUSINESS WIRE)--Cycle Pharmaceuticals (Cycle) announces the FDA approval of CAVHANZA (nilotinib) Orally Disintegrating Tablets. Launching soon, the CAVHANZA formulation is specifically designed to improve solubility and dissolution rate, enabling maintained bioavailability with concomitant use of acid-reducing agents such as proton pump inhibitors (PPIs) and\/or H\u2082 antagonists (H\u2082RAs) without timing restrictions.<sup>1<\/sup><\/p><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529885561\/en\/2821875\/5\/Circle_Logo_RGB_72dpi-Screen.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529885561\/en\/2821875\/22\/Circle_Logo_RGB_72dpi-Screen.jpg\" \/><\/a><br\/><a href=\"https:\/\/mms.businesswire.com\/media\/20260529885561\/en\/2821875\/5\/Circle_Logo_RGB_72dpi-Screen.jpg\"><img src=\"https:\/\/mms.businesswire.com\/media\/20260529885561\/en\/2821875\/21\/Circle_Logo_RGB_72dpi-Screen.jpg\" \/><\/a><p>\nThis will be a first in the nilotinib market, addressing a known challenge in Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) treatment, where 25% of patients are co-prescribed PPIs or H\u2082RAs \u2013 medications that can compromise treatment efficacy.<sup>3 <\/sup>In clinical trials, CAVHANZA demonstrated no food effect and can be taken without regard to meals, reducing food-related burden and supporting more flexible dosing, potentially improving treatment outcomes.<sup>1,2,4 <\/sup>Additionally, as an orally disintegrating tablet, CAVHANZA may support patients who have difficulty swallowing while also offering flexibility to take the treatment with or without water.<sup>1<\/sup><\/p><p>\nCAVHANZA is indicated for the treatment of:<\/p><ul class=\"bwlistdisc\">\n<li>\nNewly diagnosed adults with Ph+ CML in chronic phase; and<sup>1<\/sup><\/li>\n<li>\nAdults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.<sup>1<\/sup><\/li>\n<\/ul><p>\n\u201cWe\u2019re excited to be able to offer the CML community another TKI option that may better suit their needs,\u201d said Victoria Dickinson, Chief Product Officer at Cycle. \u201cFinding the right treatment that fits a patient\u2019s needs and lifestyle can be a stressful step in a patient\u2019s treatment journey. Bringing another option to market \u2013 backed by Cycle Vita<sup>TM<\/sup>, our dedicated patient support* program \u2013 is an exciting prospect for Cycle.\u201d<\/p><p>\nTo prepare CAVHANZA for market, Cycle partnered with Flex Pharma (Flex), who specialize in advanced formulation solutions and has developed an improved formulation of the second-generation TKI \u2013 built on years of established nilotinib efficacy.<\/p><p>\nChristian Wertz, PhD, President of Flex, added \u201cThis collaboration reflects Flex\u2019s strategy as a technology-driven company advancing differentiated 505(b)(2) oncology therapies. Leveraging our proprietary ElectroNanoSpray\u2122 (ENS) platform, we reformulate established oncology molecules to enhance bioavailability and optimize dosing performance. Together with Cycle\u2019s rare-disease commercialization expertise, we aim to efficiently deliver improved treatment options for patients with rare leukemias.\u201d<\/p><p>\nCycle has been delivering patient-focused treatments since 2017. The approval, and upcoming launch, of CAVHANZA represents the 10th product in Cycle's portfolio and the 2nd product to enhance treatment options for patients living with Ph+ CML.<\/p><p>\nLearn more about CAVHANZA at <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fcyclepharma.com%2Fchronic-myeloid-leukemia-new-treatment&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=https%3A%2F%2Fcyclepharma.com%2Fchronic-myeloid-leukemia-new-treatment&amp;index=1&amp;md5=5071cbc0459bb093f6bb6419acc69aff\" rel=\"nofollow\" shape=\"rect\">https:\/\/cyclepharma.com\/chronic-myeloid-leukemia-new-treatment<\/a>.<\/p><p>\n<b>Warning: QT Prolongation and Sudden Deaths<\/b><\/p><p>\n<b>Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments.<\/b><\/p><p>\n<b>Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome.<\/b><\/p><p>\n<b>Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors.<\/b><\/p><p>\n<b>Indications<\/b><\/p><p>\nCAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:<\/p><p>\nAdult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).<\/p><p>\nAdults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.<\/p><p>\n<b>Contraindications<\/b><\/p><p>\nCAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome.<\/p><p>\n<b>Important Safety Information<\/b><\/p><p>\n<b>Warnings and Precautions:<\/b><\/p><ul class=\"bwlistdisc\">\n<li>\nSubstitution between nilotinib products requires dose conversion to avoid medication errors.<\/li>\n<li>\nMonitor for myelosuppression; manage with dose adjustments or interruptions.<\/li>\n<li>\nCardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk.<\/li>\n<li>\nPancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations.<\/li>\n<li>\nHepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly.<\/li>\n<li>\nCorrect and monitor electrolyte abnormalities throughout treatment.<\/li>\n<li>\nTumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment.<\/li>\n<li>\nSerious hemorrhage may occur; advise patients to report signs and symptoms of bleeding.<\/li>\n<li>\nMonitor for fluid retention and manage accordingly.<\/li>\n<li>\nGrowth retardation has been reported in pediatric patients. Monitor growth and development.<\/li>\n<li>\nCan cause fetal harm; advise use of effective contraception during and 14 days after treatment.<\/li>\n<li>\nMonitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately.<\/li>\n<\/ul><p>\n<b>Adverse Reactions:<\/b><\/p><p>\nCommon non-hematologic adverse reactions include rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea and vomiting. Hematologic adverse reactions include thrombocytopenia, neutropenia, and anemia. Serious adverse reactions include QT prolongation, sudden deaths, febrile neutropenia, and intracranial hemorrhage. Postmarketing reports include thrombotic microangiopathy, facial paralysis, and osteonecrosis.<\/p><p>\n<b>Drug Interactions:<\/b><\/p><p>\nAvoid concomitant use with strong CYP3A inhibitors or inducers. Dose reduction is recommended if strong CYP3A inhibitors cannot be avoided. Avoid drugs that prolong the QT interval, including anti-arrhythmics.<\/p><p>\n<b>Use in Specific Populations:<\/b><\/p><p>\n<b>Pregnancy: <\/b>CAVHANZA can cause fetal harm when administered to a pregnant woman.<\/p><p>\n<b>Lactation: <\/b>Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose.<\/p><p>\n<b>Pediatric use: <\/b>CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used.<\/p><p>\n<i>Due to Novartis Pharmaceuticals Corporation\u2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.<\/i><\/p><p>\n<b>Geriatric use: <\/b>No major differences for safety were observed in patients \u226565 years taking CAVHANZA.<\/p><p>\n<b>For more detailed information, please refer to the full Prescribing Information at <\/b><a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fcyclepharma.com%2Fnilotinib-pi%2F&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=https%3A%2F%2Fcyclepharma.com%2Fnilotinib-pi%2F&amp;index=2&amp;md5=5f2ae9707160623deec0b1726d871790\" rel=\"nofollow\" shape=\"rect\">https:\/\/cyclepharma.com\/nilotinib-pi\/<\/a><\/p><p>\n<b>To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at <\/b><b>1-855-831-5413, or the FDA at: 1-800-FDA-1088 or <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=www.fda.gov%2Fmedwatch&amp;index=3&amp;md5=1eb54d70de343371bed43c4cb04c468c\" rel=\"nofollow\" shape=\"rect\">www.fda.gov\/medwatch<\/a>.<\/b><\/p><p>\n<b>About Cycle Pharmaceuticals<\/b><\/p><p>\nCycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK. For more information, please visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.cyclepharma.com&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=www.cyclepharma.com&amp;index=4&amp;md5=e1adb2776450ae44cab4a8028dd7dd27\" rel=\"nofollow\" shape=\"rect\">www.cyclepharma.com<\/a> and follow us on X, LinkedIn and Facebook.<\/p><p>\n<b>About Flex Pharma<\/b><\/p><p>\nFlex Pharma is a specialty pharmaceutical company focused on transforming how complex oncology drugs are formulated and delivered. Flex develops next-generation oncology formulations that enhance drug performance using its proprietary ElectroNanoSpray\u2122 (ENS) platform technology, a non-thermal spray drying process that uses electric-field forces to create fine, uniform, and amorphous particles. Flex is located in New Brighton, Minnesota. For more information, please visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.flexpharmausa.com&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=www.flexpharmausa.com&amp;index=5&amp;md5=abb57e13093faa062abbef212e58554f\" rel=\"nofollow\" shape=\"rect\">www.flexpharmausa.com<\/a> and follow on LinkedIn.<\/p><p>\n<b>References:<\/b><\/p><ol class=\"bwlistdecimal\">\n<li>\nCAVHANZA\u2122 (nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma.<\/li>\n<li>\nData on file: REF-00096<\/li>\n<li>\nData on file: REF-00097<\/li>\n<li>\nBoons, C.C.L.M., Timmers, L., Janssen, J.J.W.M. et al. Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib. Eur J Clin Pharmacol 76, 1213\u20131226 (2020). <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdoi.org%2F10.1007%2Fs00228-020-02910-3&amp;esheet=54544236&amp;newsitemid=20260529885561&amp;lan=en-US&amp;anchor=https%3A%2F%2Fdoi.org%2F10.1007%2Fs00228-020-02910-3&amp;index=6&amp;md5=fc05d77a4fbbb115f3a6ebc159261549\" rel=\"nofollow\" shape=\"rect\">https:\/\/doi.org\/10.1007\/s00228-020-02910-3<\/a> [Accessed March 26 2026].<\/li>\n<\/ol><p>\n*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.<\/p><p>\n\u00a9 2026 Cycle Pharmaceuticals Limited. All rights reserved.<\/p><p>\nCycle Vita\u2122 is a trademark of Cycle Pharmaceuticals Limited in the United States.<\/p><p>\n\u00a9 Flex Pharma 2026. All rights reserved<\/p><p>\nUS-NIL-2600029. April 2026.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n<b>FOR FURTHER INFORMATION PLEASE CONTACT<\/b><br\/><a  href=\"mailto:marketing@cyclepharma.com\" rel=\"nofollow\" shape=\"rect\">marketing@cyclepharma.com<\/a><br\/>Cycle Pharmaceuticals Limited\n<br\/>Tel: +44 1223 354 118<\/p>","protected":false},"excerpt":{"rendered":"<p>CAMBRIDGE, England&#8211;(BUSINESS WIRE)&#8211;Cycle Pharmaceuticals (Cycle) announces the FDA approval of CAVHANZA (nilotinib) Orally Disintegrating Tablets. Launching soon, the CAVHANZA formulation is specifically designed to improve solubility and dissolution&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-14893","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14893","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=14893"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14893\/revisions"}],"predecessor-version":[{"id":14894,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/14893\/revisions\/14894"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14893"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14893"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14893"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}