Cavhanza (nilotinib) / Cycle Group, Decoy Therapeutics - LARVOL DELTA

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). (Businesswire) - "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."

Launch US • Chronic Myeloid Leukemia • Philadelphia Chromosome Positive CML

Cycle Pharmaceuticals Selects Forma Life Sciences to Establish U.S. Commercial Supply for FDA-Approved CAVHANZA (nilotinib) Orally Disintegrating Tablets (Businesswire) - "CAVHANZA is an FDA-approved treatment for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Under the agreement, Forma will manufacture CAVHANZA at its facilities in Irvine, California, establishing a U.S. commercial supply as Cycle prepares to introduce the product to the U.S. market....Forma will manufacture CAVHANZA using ElectroNanoSpray, a proprietary, non-thermal particle engineering technology developed by Flex Pharma, LLC and designed to produce highly uniform amorphous drug particles."

Commercial • Chronic Myeloid Leukemia • Philadelphia Chromosome Positive CML

CAVHANZA (nilotinib) Orally Disintegrating Tablets: A New, FDA-approved Treatment Offering PPI and H2RA Flexibility for Ph+ CML Patients (Businesswire) - "CAVHANZA is indicated for the treatment of: Newly diagnosed adults with Ph+ CML in chronic phase; and; Adults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib...To 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 – built on years of established nilotinib efficacy."

FDA approval • Philadelphia Chromosome Positive CML