April 2022: I-Food and Drug Administration igunyaze i-Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., inkampani yakwaNovartis) yokwelapha iziguli ezikhulile ezinomdlavuza wendlala yesinye (PSMA) -positive metastatic castration-resistant prostate cancer ( mCRPC) abaye belashwa ngokuvinjelwa kwendlela ye-androgen receptor (AR) kanye ne-taxane-based chemotherapy.
Ngalo lolo suku, i-FDA igunyaze i-Locametz (gallium Ga 68 gozetotide), i-ejenti yokuxilonga ngemisebe ye-positron emission tomography (PET) yezilonda ze-PSMA-positive, okuhlanganisa nokukhethwa kweziguli ezinomdlavuza wendlala yesinye i-lutetium Lu 177 vipivotide tetraxetan PSMA- Ukwelashwa okuqondisiwe kubonisiwe. I-Locametz iyi-ejenti yokuqala yokuxilonga ngemisebe egunyazwe ukukhethwa kwesiguli lapho kusetshenziswa i-ejenti yokwelapha ye-radioligand.
Iziguli ezine-mCRPC eyalashwe ngaphambilini kufanele zikhethelwe ukwelashwa nge-Pluvicto kusetshenziswa i-Locametz noma enye i-ejenti yokuthwebula ye-PSMA-11 egunyaziwe esekelwe ekukhulumeni kwe-PSMA kumathumba. I-PSMA-positive mCRPC yachazwa ngokuthi inethumba okungenani elilodwa eline-gallium Ga 68 gozetotide elingaphezu kwesibindi esivamile. Iziguli bezikhishiwe ekubhaliseni uma noma yiziphi izilonda ezeqa imibandela ethile yosayizi ku-eksisi emfushane ziye zathatha ngaphansi noma ezilingana nokuthathwa kwesibindi esivamile.
Ukusebenza kahle kuhlolwe ku-VISION (NCT03511664), okungahleliwe (2:1), isivivinyo selebula elimaphakathi, elivulekile elahlola i-Pluvicto kanye nezinga elingcono kakhulu lokunakekelwa (BSoC) (n=551) noma i-BSoC iyodwa (n=280) emadodeni ane okuqhubekayo, i-PSMA-positive mCRPC. Zonke iziguli zithole i-analog ye-GnRH noma zaba ne-orchiectomy yangaphambili. Iziguli kwakudingeka ukuthi zithole okungenani i-AR pathway inhibitor eyodwa, kanye nemithi yokwelapha ngamakhemikhali esekelwe ku- taxane yangaphambili engu-1 noma emi-2. Iziguli zithole i-Pluvicto 7.4 GBq (200 mCi) njalo emavikini ayi-6 kuze kufike enanini lemithamo eyi-6 kanye ne-BSoC noma i-BSoC iyodwa.
Ukuhlolwa kubonise ukuthuthuka okuphawulekayo kwezibalo ezindaweni eziyinhloko zokusinda (OS) kanye nokusinda kwe-radiographic progression-free (rPFS). Isilinganiso se-Hazard (HR) se-OS sasingu-0.62 (95% CI: 0.52, 0.74; p<0.001) ukuze kuqhathaniswe i-Pluvicto kanye ne-BSoC ne-BSoC. I-Median OS yayiyizinyanga ezingu-15.3 (95% CI: 14.2, 16.9) engalweni ye-Pluvicto plus BSoC nezinyanga ezingu-11.3 (95% CI: 9.8, 13.5) engalweni ye-BSoC, ngokulandelana. Ukuhunyushwa kobukhulu bomphumela we-rPFS kukhawulelwe ngenxa yezinga eliphezulu lokucutshungulwa kusukela ekuphumeni kusenesikhathi engalweni yokulawula.
Ukusabela okungekuhle okuvame kakhulu (≥20%) okwenzeka ezigulini ezithola i-Pluvicto ukukhathala, umlomo owomile, isicanucanu, i-anemia, ukuncipha kwesifiso sokudla kanye nokuqunjelwa. Izifo ezivame kakhulu zaselabhorethri eziye zaba zimbi kakhulu kusukela ekuqaleni ku-≥30% ezigulini ezithola i-Pluvicto kwaba ukwehla kwama-lymphocyte, ukwehla kwe-hemoglobin, ukwehla kwama-leukocyte, ukuncipha kwamaplatelet, ukwehla kwe-calcium, nokuncipha kwe-sodium. Ukwelashwa nge-Pluvicto kungase kubangele engcupheni yokuchayeka emisebeni, i-myelosuppression, kanye nobuthi bezinso. Ubude besikhathi sokulandelela ukuphepha ku-VISION bebanele ukuthwebula ubuthi obuhlobene nemisebe sekwephuzile.
Umthamo onconyiwe we-Pluvicto ngu-7.4 GBq (200 mCi) ngokufakwa emithanjeni njalo emavikini angu-6 kufika kumithamo emi-6, noma kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
View full prescribing information for Pluvicto. View full prescribing information for Locametz.
