Dashatinib

CAMBRIDGE, England--(BUSINESS WIRE)--Cycle Pharmaceuticals (Cycle) announces the launch of CAVHANZA in the United States, offering greater dosing flexibility and potential tolerability benefits for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), while maintaining established efficacy at a 60% lower milligram strength than Tasigna® (nilotinib). 2 Made in partnership with Flex Pharma (Flex), CAVHANZA offers a distinct option within the nilotinib landscape. Administrable alongside proton pump inhibitors (PPIs) and/or H₂ receptor antagonists (H₂RAs) with no timing restrictions, the new treatment addresses a known clinical challenge, where approximately 47% of patients with Ph+ CML may also require acid-reducing agents such as PPIs that may compromise treatment bioavailability. 1,3 In addition, as the first FDA-approved ODT formulation of nilotinib, CAVHANZA offers simplified administration: tablets can be taken with or without food or water, providing flexibility for patients and supporting adherence to therapy. 1,4 Jamie Ray, Vice President - Patient Support Programs shared, “At Cycle, we’re focused on helping treatment fit more seamlessly into patients’ everyday lives. CAVHANZA offers meaningful flexibility – through PPI compatibility and fewer dietary restrictions – that may help reduce the day-to-day burden of treatment. Through Cycle Vita™, our dedicated patient support* program, we’re committed to providing the guidance, resources, and continuity of care patients need throughout their treatment journey.” Cycle has been delivering patient-focused treatments since 2017. The 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. Learn more about CAVHANZA at . Warning: QT Prolongation and Sudden Deaths 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. Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome. Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors. Indications CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy. Contraindications CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Important Safety Information Warnings and Precautions: Substitution between nilotinib products requires dose conversion to avoid medication errors. Monitor for myelosuppression; manage with dose adjustments or interruptions. Cardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk. Pancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations. Hepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly. Correct and monitor electrolyte abnormalities throughout treatment. Tumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment. Serious hemorrhage may occur; advise patients to report signs and symptoms of bleeding. Monitor for fluid retention and manage accordingly. Growth retardation has been reported in pediatric patients. Monitor growth and development. Can cause fetal harm; advise use of effective contraception during and 14 days after treatment. Monitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately. Adverse Reactions: Common 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. Drug Interactions: Avoid 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. Use in Specific Populations: Pregnancy: CAVHANZA can cause fetal harm when administered to a pregnant woman. Lactation: Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose. Pediatric use: CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used. Due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric use: No major differences for safety were observed in patients ≥65 years taking CAVHANZA. For more detailed information, please refer to the full Prescribing Information at To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or . About Cycle Pharmaceuticals Cycle 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 and follow us on X, LinkedIn and Facebook. About Flex Pharma Flex 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™ (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 and follow on LinkedIn. References: CAVHANZA (nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma. Data on file: REF-00096 Larfors, G. et al. (2023). Despite warnings, co-medication with proton pump inhibitors and dasatinib is common in chronic myeloid leukemia, but XS004, a novel oral dasatinib formulation, provides reduced pH-dependence, minimizing undesirable drug-drug interactions. European journal of haematology, [online] 111(4), pp.644–654. doi: . Ghourichay, M.P., Kiaie, S.H., Nokhodchi, A. & Javadzadeh, Y. (2021) Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives. BioMed Research International, 2021, Article ID 6618934. Available at: . *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. © 2026 Cycle Pharmaceuticals Limited. All rights reserved. © Flex Pharma 2026. All rights reserved. CAVHANZA™ is a trademark of Flex Pharma. Cycle Vita™ is a trademark of Cycle Pharmaceuticals Limited in the United States. Tasigna® is a registered trademark of Novartis AG. US-NIL-2600008. April 2026. Contacts FOR FURTHER INFORMATION PLEASE CONTACT marketing@cyclepharma.com Cycle Pharmaceuticals Limited Tel: +44 1223 354 118

Less than a year after the FDA turned down the resubmitted application for the company’s leukemia prospect Dasynoc, Xspray Pharma has again hit a wall at the U.S. regulator. This week, the FDA handed Xspray another Complete Response Letter on Dasynoc, an “optimized” version of Bristol Myers Squibb’s cancer treatment Sprycel (dasatinib) in development to tackle chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The letter addressed “previously communicated” manufacturing observations at Xspray’s third-party production partner, NerPharMa, and posed a request for additional commercial-scale batch data, which itself follows previous corrective actions, the company said in an Aug. 19 release. NerPharMa, based in Italy, has already wrapped up remediation efforts at its site and alerted the FDA of its progress, per Xspray, which acknowledged that the U.S. regulator “has yet to determine if a reinspection is required for the agency to finalize its assessment of the facility’s status.” When the FDA rebuffed Dasynoc last October, it similarly flagged concerns with Xspray’s manufacturing partner, with the company’s then-CEO Per Andersson reflecting that it was “unfortunate that manufacturing-related issues beyond our control are delaying our launch.” With the latest decision, Xspray says it now plans to resubmit its Dasynoc application as soon as possible, before the end of the year. To meet the FDA’s requests, Xspray noted that it will prioritize production of additional commercial-scale Dasynoc batches—already sewn into its launch strategy—to provide the production data the agency requires. As with the prior rejection, Xspray stressed that the FDA raised no questions around its drug candidate’s clinical data, bioequivalence or stability. The company also stressed that a risk of medication error raised in past rejections “has been resolved.” “The CRL confirms that the remaining uncertainty is now linked to NerPharMa sufficiently addressing the FDA's observations at their manufacturing site and batch data from consecutive manufacturing runs being provided,” Xspray CEO Blake Leitch said in a statement. “As expected, this will require an NDA resubmission.” In the meantime, the company says it will continue to prep for a Dasynoc launch in the U.S., with the hopes that once an approval comes through, the product can reach patients as quickly as possible. Back in February, Sweden-headquartered Xspray announced Leitch’s appointment as the company’s new chief executive, with prior helmsman Andersson transitioning into the role of chief scientific officer. The changes were designed to help with Xspray’s ongoing efforts to evolve into a commercial-stage pharmaceutical company. Xspray, which has yet to secure an FDA approval for Dasynoc or any other asset, leverages a unique business model hinging on its HyNap platform, which the company uses to design “improved versions” of cancer-fighting protein kinase inhibitor (PKI) drugs. Apart from the Sprycel-based Dasynoc, Xspray’s other lead candidate Nilopki—an optimized version of Novartis’ Tasigna—is also under FDA review. The company is also working on so-called optimized versions of Pfizer’s Inlyta and Exelixis’ Cabometyx. Prior to this week, last year’s CRL was not the first Dasynoc received. The company’s first approval effort for the drug was met with a rejection in 2023, with the FDA at the time specifically asking for clarifying information around dosing that would help patients avoid confusion. Another CRL around label comprehension and contract manufacturer concerns surfaced in 2024, but Xspray reiterated Wednesday that it has since resolved those medication error issues. The company’s stock took a sizeable hit this week on news of the latest FDA rebuff.