2021 yil avgust: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) Rezektsiya qilib bo'lmaydigan mahalliy rivojlangan yoki metastatik uch marta salbiy ko'krak bezi saratoni (mTNBC) bilan og'rigan bemorlar uchun muntazam ravishda FDA ruxsatini oldi, ular ikki yoki undan ortiq tizimli davolanishni olgan, ulardan kamida bittasi metastatik kasallik bo'lgan.
Sacituzumab govitecan, ilgari metastatik kasallik uchun kamida ikkita davolanishga ega bo'lgan mTNBC bilan og'rigan bemorlar uchun 2020 yil aprel oyida tez tasdiqlangan. Tezroq tasdiqlash uchun tasdiqlovchi sud keyingi qadam bo'ldi.
Efficacy and safety were assessed in 529 patients with unresectable locally advanced or mTNBC who had relapsed after at least two prior chemotherapies, one of which could have been in the neoadjuvant or adjuvant setting, if progression occurred within 12 months, in a multicenter, open-label, randomised trial (ASCENT; NCT02574455). On days 1 and 8 of a 21-day (n=267) cycle, patients were randomised (1:1) to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, or a physician’s choice of single agent chemotherapy (n=262).
The primary effectiveness outcome was progression-free survival (PFS) in patients who did not have brain metastases at the start of the study, as determined by a blinded, independent, centralised review using RECIST 1.1 criteria. PFS for the entire cohort (with and without brain metastases) and overall survival were also included as effectiveness objectives (OS).
Sacituzumab govitecanni qabul qilgan bemorlarda kimyoterapiya (HR 4.8; 95 foiz ishonch oralig'i: 4.1, 5.8 oy) (1.7 foiz ishonch oralig'i: 95, 1.5) bilan solishtirganda o'rtacha PFS 2.5 oy (0.43 foiz ishonch oralig'i: 95, 0.35) bo'lgan. 0.54; p0.0001). O'rtacha OS erkaklar uchun 11.8 oy (95 foiz ishonch oralig'i: 10.5, 13.8) va ayollar uchun 6.9 oy (95 foiz ishonch oralig'i: 5.9, 7.6) (HR 0.51; 95 foiz ishonch oralig'i: 0.41, 0.62; p0.0001) .
Sakituzumab govitekanni qabul qilgan bemorlarda ko'ngil aynishi, neytropeniya, diareya, letargiya, alopesiya, anemiya, qusish, ich qotishi, toshma, ishtahaning pasayishi va qorinda noqulaylik eng ko'p uchraydigan yon hodisalardir (insidans> 25%).
Kasallik rivojlanmaguncha yoki toqat qilib bo'lmaydigan zaharlanishgacha, gatsituzumabning tavsiya etilgan dozasi 10 kunlik terapiya sikllarining 1 va 8-kunlarida haftasiga bir marta 21 mg/kg ni tashkil qiladi.
Malumot: https://www.fda.gov/
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