Smaller dose, new regimen recommended for pexidartinib in TGCT after post-marketing data
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A reduced dosage and updated regimen are now available for the oral small molecule pexidartinib in the treatment of adults with symptomatic tenosynovial giant cell tumor, according to a press release from the drug manufacturer.
The new recommended dose of pexidartinib (Turalio, Daiichi Sankyo) is 250 mg twice daily, taken as two 125 mg capsules, with a low-fat meal of approximately 11 gm to 14 gm of total fat, until disease progression or unacceptable toxicity. The previous dosage and regimen — 400 mg twice daily on an empty stomach — is no longer recommended after post-marketing studies revealed an increased risk for adverse reactions with the drug when taken with a high-fat meal. Additionally, data showed that 250 mg of pexidartinib with a low-fat meal demonstrated comparable efficacy to the previous dosage and regimen.
“The new dose reflects study data that evaluated the impact of food on Turalio exposure should patients not follow the previous recommended dietary requirements when taking the medication,” Dan Switzer, head of U.S. Oncology Business for Daiichi Sankyo, said in the company release. “As patient safety is our primary goal, we will continue to inform health care professionals about the new dosing regimen of Turalio so that they can continue to treat appropriate patients with tenosynovial giant cell tumor (TGCT) with the only FDA-approved therapy.”
To fulfill post-marketing requirements mandated by the FDA following approval, Daiichi Sankyo conducted a series of pharmacokinetic studies examining the effects of food when taking pexidartinib. According to the company, taking pexidartinib with a high-fat meal — 55 gm to 65 gm of total fat — increases the drug’s concentration in the body and may increase the risk for adverse reactions, including hepatotoxicity.
These studies additionally demonstrated that lowering the dose and ingesting it with a low-fat meal helps to minimize the risk for overexposure in the event the patient fails to carefully follow the dietary recommendations when taking the higher dose. Lastly, the studies found that 250 mg of twice daily pexidartinib, with a low-fat meal, resulted in no clinically significant difference in efficacy vs. 400 mg twice daily on an empty stomach.
The previous recommended dosage of 400 mg had been administered in two 200 mg capsules, which have now been discontinued. Patients currently taking pexidartinib 200 mg capsules can receive the new 125 mg capsules as the next scheduled dose once the 200 mg capsules have been finished, according to the company. Patients should consult with their physicians to answer any questions they may have as they transition to the new dose, the release said.
Pexidartinib is approved for TGCT with a boxed warning for hepatotoxicity due to the risk for serious and potentially fatal liver injury.
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