Nuwamba 2023: Hukumar Abinci da Magunguna ta amince da HEPZATO KIT (melphalan don allura / tsarin isar da hanta, Delcath Systems, Inc.) azaman jiyya ta hanta ga manya marasa lafiya tare da uveal melanoma waɗanda ke da metastases na hanta wanda ba a iya jurewa ba wanda ke shafar ƙasa da 50% na hanta. babu wata cuta mai saurin haifuwa, ko cutar da ta ke da iyaka ga huhu, kashi, lymph nodes, ko kyallen jikin jiki kuma tana iya zama.
A cikin binciken FOCUS (NCT02678572), mutane 91 da ke da melanoma na uveal da hanta da ba za a iya cire su ba sun shiga cikin hannu guda ɗaya, gwajin lakabin budewa don ganin yadda maganin ya yi aiki. Idan mafi haɗari na uveal melanoma ya fito ne daga hanta kuma ana iya magance cutar da ke waje da hanta tare da maganin radiation ko tiyata, to, ana iya samun wasu cututtuka a waje da hanta a cikin huhu, lymph nodes, kashi, ko karkashin fata. . Mahimman dalilai na rashin cancanta sune ciwon metastases a cikin akalla 50% na hanta parenchyma, ciwon Child-Pugh Class B ko C cirrhosis, ko ciwon hanta B ko C.
Babban hanyoyin da za a auna yadda wani abu ya yi aiki da kyau shine ƙimar amsawar haƙiƙa (ORR) da kuma tsawon lokacin amsawa (DoR), waɗanda wani kwamitin nazari na gaskiya ya yanke shawara ta amfani da RECIST v1.1. DoR na tsakiya shine watanni 14 (95% CI: 8.3, 17.7), kuma ORR ya kasance 36.3% (95% CI: 26.4, 47).
Ana shigar da Melphalan (HEPZATO) a cikin jijiyar hanta kowane mako 6 zuwa 8 don iyakar jiko 6 ta amfani da Tsarin Isar da Hanta (HDS), ɓangaren na'urar. Dangane da madaidaicin nauyin jiki, adadin melphalan da aka ba da shawarar shine 3 mg/kg, tare da matsakaicin kashi na 220 MG a cikin jiyya ɗaya.
Akwai Gargaɗi na Akwati game da mummunan sakamako na tsari, kamar zubar jini, lalacewar hanta, da abubuwan da suka faru na thromboembolic, a cikin kayan da aka tsara don KIT na HEPZATO. Gargadi na Akwati game da kawar da myelos da yuwuwar kamuwa da cuta mai tsanani, zubar jini, ko anemia mai alama ana kuma haɗa shi cikin kayan da aka rubuta.
Saboda yuwuwar sakamako mai tsanani kamar abubuwan da suka faru na thromboembolic, lalacewar hepatocellular, da zubar jini, HEPZATO KIT yana samuwa ne kawai ta hanyar ƙayyadaddun shirin da ya faɗo ƙarƙashin Ƙididdigar Haɗarin HEPZATO KIT da Dabarun Ragewa.
Thrombocytopenia, gajiya, anemia, tashin zuciya, ciwon musculoskeletal, leukopenia, ciwon ciki, neutropenia, amai, ƙara alanine aminotransferase, tsawaita aiki partial thromboplastin lokaci, ƙara aspartate aminotransferase, ƙara jini alkaline phosphatase, da dyspnea sun kasance mafi na kowa (20%). mummunan halayen ko rashin daidaituwa na dakin gwaje-gwaje.
HEPZATO da HEPZATO KIT an hana su a cikin marasa lafiya tare da metastases na intracranial mai aiki ko raunin kwakwalwa tare da yiwuwar zubar jini; gazawar hanta, hauhawar jini na portal, ko sanantattun varices da ke cikin haɗarin zub da jini; tiyata ko magani na hanta a cikin makonni 4 da suka gabata; coagulopathy wanda ba a daidaita shi ba, rashin iya jurewa shan maganin sa barci na yau da kullun, gami da yanayin zuciya mai aiki ciki har da, amma ba'a iyakance ga, cututtuka marasa ƙarfi na jijiyoyin jini (rashin ƙarfi ko mai tsanani angina ko ciwon zuciya na zuciya), daɗaɗawa ko ciwon zuciya mai saurin tasowa, babban arrhythmias, ko cututtukan valvular. ; tarihin allergies ko sananne hypersensitivity zuwa melphalan; tarihin rashin lafiyar jiki ko sanannen rashin hankali ga wani sashi ko kayan da ake amfani da su a cikin HEPZATO KIT gami da tarihin rashin lafiyar latex na roba na halitta; tarihin rashin lafiyar ko rashin jin daɗi ga heparin ko kasancewar heparin-induced thrombocytopenia (HIT); da kuma tarihin rashin lafiyar rashin lafiyar mai tsanani ga bambancin iodinated ba a sarrafa shi ta hanyar premedication tare da antihistamines da steroids.
