Agusta 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) sun sami izinin FDA na yau da kullun ga marasa lafiya waɗanda ke da ci gaba a cikin gida ko metastatic cutar kansar nono mai sau uku (mTNBC) waɗanda suka karɓi jiyya biyu ko fiye kafin tsarin tsarin, aƙalla ɗaya daga cikinsu na rashin lafiya ne.
An ba da izinin Sacituzumab govitecan cikin hanzari a cikin Afrilu 2020 don marasa lafiya tare da mTNBC waɗanda a baya suna da aƙalla jiyya biyu don rashin lafiya. Gwajin tabbatarwa don amincewa cikin sauri shine mataki na gaba.
An ƙididdige inganci da aminci a cikin marasa lafiya 529 waɗanda ke da ci gaba a cikin gida ko mTNBC waɗanda ba a iya gano su ba waɗanda suka sake dawowa bayan aƙalla maganin chemothera biyu na farko, ɗayan wanda zai iya kasancewa a cikin neoadjuvant ko saitin adjuvant, idan ci gaba ya faru a cikin watanni 12, a cikin multicenter, buɗe- lakabin, gwajin bazuwar (ASCENT; NCT02574455). A kwanakin 1 da 8 na zagaye na 21-day (n = 267), marasa lafiya sun kasance bazuwar (1: 1) don karɓar sacituzumab govitecan, 10 mg / kg a matsayin jiko na cikin jini, ko zaɓin likita na maganin chemotherapy guda ɗaya (n=) 262).
Sakamakon tasiri na farko shine rayuwa marar ci gaba (PFS) a cikin marasa lafiya waɗanda ba su da ciwon kwakwalwa a farkon binciken, kamar yadda aka ƙaddara ta makanta, mai zaman kanta, nazari na tsakiya ta amfani da ma'auni na RECIST 1.1. PFS ga dukan ƙungiyar (tare da kuma ba tare da metastases na kwakwalwa ba) da kuma rayuwa gabaɗaya an kuma haɗa su azaman manufofin inganci (OS).
Marasa lafiya da ke karɓar sacituzumab govitecan suna da tsaka-tsaki na PFS na watanni 4.8 (kashi 95 tazarar amincewa: 4.1, 5.8) idan aka kwatanta da watanni 1.7 (lokacin amincewa da kashi 95: 1.5, 2.5) a cikin waɗanda ke karɓar chemotherapy (HR 0.43; 95 kashi tazara tazara, 0.35) 0.54; p0.0001). Tsakanin OS ya kasance watanni 11.8 (95 bisa dari tazarar amincewa: 10.5, 13.8) na maza da watanni 6.9 (tsakanin amincewa kashi 95: 5.9, 7.6) na mata (HR 0.51; 95 kashi tazarar amincewa: 0.41, 0.62; p0.0001) .
Tashin zuciya, neutropenia, zawo, lethargy, alopecia, anemia, amai, maƙarƙashiya, rash, rage cin abinci, da rashin jin daɗi na ciki sune mafi yawan abubuwan da ke faruwa a gefe (abin da ya faru> 25%) a cikin marasa lafiya da ke shan sacituzumab govitecan.
Har sai cutar ta ci gaba ko cutar da ba za a iya jurewa ba, shawarar sacituzumab govitecan kashi shine 10 mg/kg sau ɗaya a mako a ranakun 1 da 8 na hawan keke na kwana 21.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
