IRVINE, Calif., August 12, 2026
Cycle Pharmaceuticals announced a commercial manufacturing agreement with Forma Life Sciences to establish a U.S. commercial supply of CAVHANZA™ (nilotinib) orally disintegrating tablets, supporting the company’s preparations to introduce the FDA-approved treatment to patients in the United States. Under the agreement, Forma Life Sciences will manufacture CAVHANZA at its facility in Irvine, California, providing domestic commercial manufacturing capabilities as Cycle advances its U.S. launch plans. CAVHANZA is approved for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), a form of blood cancer driven by the Philadelphia chromosome and associated BCR-ABL signaling. The manufacturing agreement represents an important operational milestone because establishing reliable commercial supply is a critical requirement for transitioning an approved medicine toward broader market availability. Cycle Pharmaceuticals said the collaboration builds on its preparations for the U.S. commercialization of CAVHANZA and leverages Forma’s expertise in complex oral drug product manufacturing.
CAVHANZA Offers Administration Advantages
CAVHANZA was developed to address several administration challenges associated with conventional nilotinib products, potentially providing greater flexibility for patients and healthcare professionals managing Ph+ CML. Unlike conventional nilotinib formulations, CAVHANZA can be administered with proton pump inhibitors (PPIs) and H2 receptor antagonists without timing restrictions, addressing a practical consideration because acid-reducing medications are commonly used by patients. According to Cycle, approximately 47% of patients with Ph+ CML are prescribed PPIs at some point following diagnosis, creating potential challenges related to treatment administration and drug bioavailability with conventional formulations. CAVHANZA also demonstrated no food effect in clinical studies, allowing patients to take the medicine without regard to meals. In addition, its orally disintegrating tablet formulation can be taken with or without water, potentially providing an alternative for patients who experience difficulty swallowing conventional tablets. These formulation characteristics are intended to simplify administration while maintaining treatment access for adults requiring nilotinib therapy.
Forma Technology Supports Commercial Manufacturing
Forma Life Sciences will manufacture CAVHANZA using ElectroNanoSpray™, a non-thermal particle engineering technology developed by Flex Pharma, LLC. The technology is designed to produce highly uniform amorphous drug particles and forms part of the manufacturing approach supporting CAVHANZA. Forma has previously supported the product through development toward commercial manufacturing and will continue providing manufacturing services under the new agreement. The company operates as a U.S. contract development and manufacturing organization (CDMO) specializing in formulation development, analytical services, clinical manufacturing and commercial supply for oral solid dosage products. Its capabilities include spray drying, hot melt extrusion, particle engineering and other technologies used in the development and manufacture of complex pharmaceutical formulations. For Cycle Pharmaceuticals, establishing domestic manufacturing capacity represents a step toward strengthening the commercial supply chain for CAVHANZA ahead of its planned U.S. market introduction.
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Cycle Pharmaceuticals Advances U.S. Commercialization
The agreement comes as Cycle Pharmaceuticals prepares to commercialize CAVHANZA in the United States, following its FDA approval for adults with Ph+ CML. Cycle focuses on developing and delivering treatments for rare and underserved diseases, with activities spanning metabolic disorders, immunology, urology, oncology and neurology. CAVHANZA provides the company with a differentiated pharmaceutical product based on the established active ingredient nilotinib while offering additional administration flexibility through its orally disintegrating formulation. The company’s partnership with Forma is therefore focused not on clinical development of a new investigational therapy, but on manufacturing readiness and commercial supply for an already approved medicine. If the U.S. launch proceeds as planned, dependable domestic production could help support product availability and distribution as Cycle introduces CAVHANZA to the American market. The development also highlights the importance of specialized pharmaceutical manufacturing capabilities in bringing differentiated drug formulations from regulatory approval to commercial availability.
Source:Forma Life Sciences,,press release
