{"id":53516,"date":"2023-02-01T14:04:23","date_gmt":"2023-02-01T13:04:23","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/turalio-new-dosing-regimen-now-available-in-the-u-s-for-certain-patients-with-tenosynovial-giant-cell-tumor\/"},"modified":"2023-02-01T14:04:23","modified_gmt":"2023-02-01T13:04:23","slug":"turalio-new-dosing-regimen-now-available-in-the-u-s-for-certain-patients-with-tenosynovial-giant-cell-tumor","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/turalio-new-dosing-regimen-now-available-in-the-u-s-for-certain-patients-with-tenosynovial-giant-cell-tumor\/","title":{"rendered":"TURALIO\u00ae New Dosing Regimen Now Available in the U.S. for Certain Patients with Tenosynovial Giant Cell Tumor"},"content":{"rendered":"
\n

BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) today announced that the new dosing regimen for TURALIO\u00ae<\/sup> (pexidartinib) is now available in the U.S. for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. A new 125 mg capsule of TURALIO is now available and the 200 mg capsule has been discontinued.\n<\/p>\n

<\/a><\/p>\n

\nTGCT is a rare, typically non-malignant tumor that affects small and large joints. The disease can cause debilitating symptoms, can be locally aggressive and can significantly impact everyday activities in a relatively young patient population.1,2,3<\/sup>\n<\/p>\n

\nThe new recommended dose of TURALIO is 250 mg orally twice daily (taken as two 125 mg capsules) with a low-fat meal of approximately 11 to 14 grams of total fat until disease progression or unacceptable toxicity. The previous dose was 400 mg orally twice daily on an empty stomach. Patients currently taking TURALIO 200 mg capsules can take the 125 mg capsules as the next scheduled dose once the 200 mg capsules have been finished. Patients should consult with their physicians to answer any questions they may have as they transition to the new dose.\n<\/p>\n

\nAs part of post-marketing requirements with the U.S. Food and Drug Administration (FDA), Daiichi Sankyo conducted pharmacokinetic studies to evaluate the effects of food when taking TURALIO. Taking TURALIO with a high-fat meal (approximately 55 to 65 grams of total fat) was found to increase the concentration of TURALIO in the body and may increase the risk of adverse reactions, including hepatotoxicity. These studies demonstrated that lowering the dose of TURALIO and taking it with a low-fat meal helps to minimize the potential for drug overexposure in the event a patient did not carefully follow the dietary recommendations when taking the 200 mg capsule of TURALIO. Studies also showed that taking TURALIO 250 mg with a low-fat meal (11 to 14 grams of total fat) has no clinically significant difference in efficacy to taking TURALIO 400 mg on an empty stomach.\n<\/p>\n

\n\u201cThe 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,\u201d said Dan Switzer, Head of U.S. Oncology Business, Daiichi Sankyo, Inc. \u201cAs patient safety is our primary goal, we will continue to inform healthcare professionals about the new dosing regimen of TURALIO so that they can continue to treat appropriate patients with tenosynovial giant cell tumor with the only FDA-approved therapy.\u201d\n<\/p>\n

\nTURALIO is approved with a Boxed WARNING for hepatotoxicity due to the risk of serious and potentially fatal liver injury. Hepatotoxicity with ductopenia and cholestasis has occurred in patients treated with TURALIO. Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury. One patient died with advanced cancer and ongoing liver toxicity and one patient required a liver transplant. The mechanism of cholestatic hepatotoxicity is unknown and its occurrence cannot be predicted. It is unknown whether liver injury occurs in the absence of increased transaminases. Because of the risk of hepatotoxicity, TURALIO is available by prescription in the U.S. only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program where only certified healthcare providers may prescribe TURALIO. Patients must complete and sign an enrollment form for inclusion in a patient registry to receive treatment. Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive TURALIO.\n<\/p>\n

\nDaiichi Sankyo is committed to ensuring that patients in the U.S. who are prescribed TURALIO can access the medication and receive necessary financial support. Provider and patient support related to access, reimbursement and distribution for TURALIO in the U.S. will be accessible through Daiichi Sankyo Access Central by visiting www.DSIAccessCentral.com<\/a> or calling 1-866-4-DSI-NOW (1-866-437-4669).\n<\/p>\n

\nFurther information is available at www.TURALIOREMS.com<\/a>. For more information, please visit www.TURALIO.com<\/a> for full Prescribing Information<\/a>, including Boxed WARNING, and for additional Important Safety Information.\n<\/p>\n

\nAbout TGCT (PVNS\/GCT-TS)
\n
<\/b>TGCT, also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a rare, typically non-malignant tumor that can be locally aggressive. TGCT affects the synovium-lined joints, bursae and tendon sheaths, resulting in reduced mobility in the affected joint or limb.1,2,3<\/sup>\n<\/p>\n

\nWhile the exact incidence of TGCT is not known, it is estimated that the worldwide incidence of TGCT is 43 patients per million person-years.4,5,6<\/sup> TGCT is subcategorized into two types: localized, which is more common and accounts for 80% to 90% of cases, and diffuse, which accounts for 10% to 20% of cases.5,6<\/sup>\n<\/p>\n

\nThe current standard of care for TGCT is surgical resection.1,7<\/sup> However, in patients with recurrent, difficult-to-treat, or the diffuse form of TGCT, the tumor may wrap around bone, tendons, ligaments and other parts of the joint. In these cases, the tumor may be difficult to remove and\/or may not be amenable to improvement with surgery. Multiple surgeries for more severe cases can lead to significant joint damage, debilitating functional impairments and reduced quality of life, and amputation may be considered.7,8,9<\/sup>\n<\/p>\n

\nRecurrence rates for localized TGCT are estimated to be up to 15% following complete resection. 3,6,10,11,12<\/sup> Diffuse TGCT recurrence rates are estimated to be up to 55% following complete resection.3,6,10,13<\/sup> TGCT affects all age groups with the diffuse type on average occurring most often in people below the age of 40, and the localized type typically occurring in people between 30 and 50 years old.1,4,5,6<\/sup>\n<\/p>\n

\nAbout TURALIO
\n
<\/b>TURALIO (pexidartinib) is an oral small molecule that targets colony stimulating factor 1 receptor (CSF1R), KIT proto-oncogene receptor tyrosine kinase (KIT), and FMS-like tyrosine kinase 3 (FLT3) harboring an internal tandem duplication (ITD) mutation. Overexpression of the CSF1R ligand promotes cell proliferation and accumulation in the synovium.\n<\/p>\n

\nTURALIO is approved in the U.S. for the treatment of adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The medicine was granted Priority Review, Breakthrough Therapy and Orphan Drug Designation by the U.S. FDA prior to FDA approval in August 2019.\n<\/p>\n

\nImportant Safety Information
\n
<\/b>Indication and Usage
\n
<\/b>TURALIO\u24c7<\/sup> (pexidartinib) is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.\n<\/p>\n\n\n\n
\n

\nWARNING: HEPATOTOXICITY<\/b>\n<\/p>\n<\/td>\n<\/tr>\n

\n