Cycle Pharmaceuticals has selected Forma Life Sciences to establish U.S. commercial manufacturing supply for Cavhanza, an FDA-approved orally disintegrating nilotinib tablet for adults with Philadelphia chromosome-positive chronic myeloid leukemia.
Under the commercial manufacturing agreement, Forma will produce Cavhanza at its facilities in Irvine, California, as Cycle prepares to introduce the treatment to the U.S. market. The companies said the arrangement advances Cycle’s commercialization plans and strengthens domestic supply for the medicine.
Cavhanza is approved for adults newly diagnosed with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia, as well as adults with chronic- or accelerated-phase disease that is resistant or intolerant to prior therapy, including imatinib.
The treatment was developed to address administration challenges associated with conventional nilotinib products. Cavhanza can be taken with proton pump inhibitors and H2 receptor antagonists without timing restrictions. Cycle said this is important because 47% of patients with Philadelphia chromosome-positive chronic myeloid leukemia are prescribed proton pump inhibitors at some point after diagnosis, which can affect treatment bioavailability.
Clinical studies also showed no food effect, allowing Cavhanza to be taken without regard to meals. As an orally disintegrating tablet, it may be taken with or without water, potentially offering greater flexibility for people who have difficulty swallowing conventional tablets.
Forma will manufacture the product using ElectroNanoSpray, a non-thermal particle-engineering technology developed by Flex Pharma. The technology is designed to create highly uniform amorphous drug particles. Forma has supported Cavhanza during its progression toward commercial manufacturing and will continue providing manufacturing services to Cycle under the new agreement.
Catherine Wainwright, Cycle’s chief operations and regulatory officer, said establishing U.S. production is an important step toward bringing the differentiated treatment to patients. Forma President Armand Amin said the company will apply its experience in complex oral drug products and commercial manufacturing to support the launch.
Cavhanza carries a warning for QT prolongation and sudden deaths. The label advises monitoring electrolytes and ECGs, and avoiding use in patients with hypokalemia, hypomagnesemia or long QT syndrome. It also warns against combining the drug with QT-prolonging medicines or strong CYP3A4 inhibitors.