2022 sentyabr: The European Commission (EC) has authorized Kite’s CAR T-hujayra terapiyasi Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and older with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia. Kite is a Gilead Company (Nasdaq: GILD) (ALL).
Kite kompaniyasining bosh direktori Kristi Shouning so'zlariga ko'ra, "Ushbu ma'qullash bilan Tecartus bu bemor populyatsiyasi uchun tavsiya etilgan birinchi va yagona CAR T-hujayrali terapiya bo'lib, katta qondirilmagan tibbiy ehtiyojni qondiradi". Bu, shuningdek, Evropada Kite xujayrasi terapiyasining to'rtinchi tasdiqlangan qo'llanilishi bo'lib, ularning bemorlarga, xususan, boshqa terapevtik muqobillari bo'lganlarga beradigan afzalliklarini ko'rsatadi.
The most prevalent type of BARCHA, which is an aggressive blood malignancy, is B-cell precursor ALL. Annually, ALL is diagnosed in about 64,000 people worldwide. With the current standard-of-care medications, the median overall survival (OS) for individuals with ALL is just about eight months.
According to Max S. Topp, MD, professor and director of haematology at the University Hospital of Wuerzburg in Germany, “adults with relapsed or refractory ALL frequently undergo multiple treatments, including chemotherapy, targeted therapy, and stem cell transplant, creating a significant burden on a patient’s quality of life.” Patients in Europe today benefit from a significant improvement in care. Durable responses from Tecartus point to the possibility of a long-term remission and a novel treatment strategy.
ZUMA-3 xalqaro ko'p markazli, bir qo'lli, ochiq yorliqli, ro'yxatga olish bosqichi 1/2 bo'lgan kattalar (18 yosh) ALL relapsli yoki refrakter ALL bilan o'tkazilgan tadqiqot tasdiqlashni qo'llab-quvvatlovchi natijalarni taqdim etdi. O'rtacha 26.8 oylik kuzatuv bilan ushbu tadqiqot baholanadigan bemorlarning 71 foizi (n = 55) to'liq remissiya (CR) yoki qisman gematologik tiklanish (CRi) bilan CRni boshdan kechirganini ko'rsatdi. Kattaroq ma'lumotlar to'plamida asosiy dozalarni (n = 78) olgan barcha bemorlar uchun o'rtacha umumiy omon qolish ikki yildan ortiq (25.4 oy) va javob berganlar uchun deyarli to'rt yil (47 oy) edi (CR ga erishgan bemorlar). yoki CRi). Samaradorligi baholanishi mumkin bo'lgan bemorlarda remissiyaning o'rtacha davomiyligi (DOR) 18.6 oyni tashkil etdi.
The safety outcomes among the patients given Tecartus at the target dose (n=100) were consistent with the drug’s known safety profile. 25% and 32% of patients, respectively, experienced grade 3 or higher sitokinlarni chiqarish sindromi (CRS) and neurologic adverse events, which were typically adequately controlled.
