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Danziten, a new formulation of nilotinib, may improve treatment adherence in patients with Philadelphia chromosome-positive chronic myeloid leukemia.
The FDA has approved Danziten, a new formulation of nilotinib, for adults with newly diagnosed or resistant Philadelphia chromosome-positive chronic myeloid leukemia that does not require fasting.
The Food and Drug Administration (FDA) approved Danziten, a formulation of nilotinib, that requires no mealtime restrictions for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and for adults with chronic phase and acute phase resistant or intolerant to prior therapy with Gleevec (imatinib).
The approval was announced in a press release from Azurity Pharmaceuticals, the manufacturer of Danziten. The goal with Danziten is to potentially improve adherence to the drug as a result of removing the fasting requirements of Tasgina, another formulation of nilotinib.
The release also stated that Danziten will be available in the coming weeks.
“Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna but without the fasting requirements of Tasigna,” Richard Blackburn, CEO of Azurity Pharmaceuticals, said in the release. “Unlike Tasgina, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating (chronic myeloid leukemia) patients from mealtime restrictions.”
Pharmacokinetics: the activity of drugs in the body over time, which includes how drugs are absorbed in the body, distributed, localized in tissues and excreted.
Tyrosine kinase inhibitor: a targeted therapy that blocks certain enzymes that may be too active in cancer cells, resulting in the blocking of cancer cell growth.
Of note, Tasigna has been shown to be effective in adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia and those with resistant or intolerant Philadelphia chromosome-positive either in chronic phase or acute phase.
Despite its effectiveness, it is recommended for Tasigna to be taken while fasting due to its variable bioavailability, or the amount of a drug that reaches the bloodstream and has an effect on the body. If taken with food, Tasigna may result in a significantly prolonged QT interval, meaning that it takes longer for the heart to return to its resting state in between heartbeats. Hence, the emphasis on strict fasting when taking Tasigna, according to the release.
Danziten, on the other hand, is a re-engineered formulation of nilotinib that has been shown to be as effective as Tasigna but with improved bioavailability, leading to a lower dose. In addition, Danziten has demonstrated consistent pharmacokinetics with no clinically significant differences to nilotinib regardless of fasting or meal type, the release noted.
Nilotinib, according to the National Cancer Institute, is a tyrosine kinase inhibitor to treat certain types of chronic myelogenous leukemia that are considered Philadelphia chromosome-positive. The drug is meant to block certain proteins that may prevent cancer cells from growing.
The release explained that with tyrosine kinase inhibitor therapy, patients with Philadelphia chromosome-positive chronic myeloid leukemia can achieve deep molecular responses, and some may achieve treatment-free remission. In fact, the life expectancy of patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia who respond to treatment has been getting close to the life expectancy of the general population. Despite this improvement, there are several challenges including treatment adherence.
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