FDA approves dissolving formulation of leukemia drug nilotinib
New version of CML treatment eliminates need for fasting, absorbs more efficiently
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The U.S. Food and Drug Administration (FDA) has approved a new formulation of the anticancer therapy nilotinib, branded Cavhanza, to treat certain people with chronic myeloid leukemia (CML), a form of blood cancer.
Previous formulations of nilotinib are capsules or tablets that are swallowed and processed through the digestive tract. Cavhanza is a tablet version designed to disintegrate in the mouth, which the therapy’s maker Cycle Pharmaceuticals said should allow the drug to be more efficiently absorbed in patients who are taking medications to control stomach acid.
Like other formulations of nilotinib, Cavhanza is indicated to treat newly diagnosed adults with CML carrying a genetic abnormality called the Philadelphia chromosome who are in the chronic phase, the earliest stage of disease when progression is slow and symptoms are minimal, as well as adults in the chronic or accelerated phase who are Philadelphia-positive and stopped responding to or did not tolerate prior therapy.
“We’re excited to be able to offer the CML community another [treatment] option that may better suit their needs,” Victoria Dickinson, chief product officer at Cycle, said in a company press release.
Seeking a more efficient, flexible option
The Philadelphia chromosome is a genetic mutation that leads to the production of an abnormal fusion protein called BCR::ABL1 that drives cancer growth. Nilotinib is designed to block the activity of this abnormal and hyperactive protein, halting cancer cell growth.
Medications to reduce stomach acid can interfere with the body’s ability to absorb traditional formulations of nilotinib that are processed through the digestive tract, leading to reduced efficacy. Yet roughly one in four people with CML is taking these medications, according to Cycle.
Another drawback of previous nilotinib formulations is that patients must have an empty stomach for a few hours before and after taking the medication. Food can significantly increase the amount of the drug the body absorbs, potentially increasing the risk of side effects.
The orally disintegrating tablet aims to avoid these issues. The newly approved therapy can be taken with or without food, making dosing more flexible. The dissolving formulation can also benefit patients who have difficulty swallowing.
Cycle offers a support program, Cycle Vita, that provides emotional, financial, and product support to qualifying patients.
“Finding the right treatment that fits a patient’s needs and lifestyle can be a stressful step in a patient’s treatment journey,” Dickinson said. “Bringing another option to market – backed by Cycle Vita, our dedicated patient support program – is an exciting prospect for Cycle.”
Cycle said it expects to commercially launch Cavhanza soon. The company has partnered with Flex Pharma, a company specializing in advanced formulation solutions, to develop the therapy.
“This collaboration reflects Flex’s strategy as a technology-driven company advancing differentiated [cancer] therapies,” said Christian Wertz, PhD, president of Flex. “Together with Cycle’s rare-disease commercialization expertise, we aim to efficiently deliver improved treatment options for patients with rare leukemias.”
