Afrilu 2022: Hukumar Abinci da Magunguna ta amince da Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., wani kamfanin Novartis) don kula da manya marasa lafiya tare da takamaiman membran antigen (PSMA) - tabbataccen ƙwayar cuta mai jurewa prostate ciwon daji (PSMA). mCRPC) waɗanda aka bi da su tare da hanawar hanyar mai karɓar mai karɓar isrogen (AR) da chemotherapy na tushen haraji.
A wannan rana, FDA ta amince da Locametz (gallium Ga 68 gozetotide), wakili na bincike na rediyo don positron emission tomography (PET) na raunuka masu kyau na PSMA, ciki har da zaɓi na marasa lafiya da ciwon daji na prostate wanda lutetium Lu 177 vipivotide tetraxetan PSMA- ana nuna farfaganda. Locametz shine wakili na farko na bincike na rediyo wanda aka amince don zaɓin haƙuri a cikin amfani da wakili na warkewa na radioligand.
Ya kamata a zaɓi marasa lafiya tare da mCRPC da aka bi da su a baya don magani tare da Pluvicto ta amfani da Locametz ko wani wakilin hoto na PSMA-11 da aka amince da shi bisa bayanin PSMA a cikin ciwace-ciwacen daji. An bayyana PSMA-tabbatacce mCRPC a matsayin yana da aƙalla raunin ƙwayar cuta guda ɗaya tare da gallium Ga 68 gozetotide sama da hanta ta al'ada. An cire marasa lafiya daga yin rajista idan duk wani rauni da ya wuce wasu ma'auni mai girma a cikin gajeren axis yana da haɓaka ƙasa da ko daidai da ɗauka a cikin hanta ta al'ada.
An kimanta inganci a cikin VISION (NCT03511664), bazuwar (2: 1), multicenter, gwajin lakabin buɗewa wanda ya kimanta Pluvicto da mafi kyawun ƙimar kulawa (BSoC) (n=551) ko BSoC kadai (n=280) a cikin maza tare da m, PSMA-tabbatacce mCRPC. Duk marasa lafiya sun sami analog na GnRH ko sun riga sun sami orchiectomy na gefe biyu. Ana buƙatar marasa lafiya su sami aƙalla mai hanawa ta hanyar AR guda ɗaya, da 1 ko 2 kafin tsarin ilimin chemotherapy na tushen haraji. Marasa lafiya sun karɓi Pluvicto 7.4 GBq (200mCi) kowane mako 6 har zuwa jimlar allurai 6 da BSoC ko BSoC kaɗai.
Gwajin ya nuna ci gaba mai mahimmanci na ƙididdiga a cikin farkon ƙarshen ƙarshen rayuwa gabaɗaya (OS) da rayuwa mara-kyau ta rediyo (rPFS). Matsayin Hazard (HR) na OS shine 0.62 (95% CI: 0.52, 0.74; p<0.001) don kwatancen Pluvicto da BSoC da BSoC. Median OS ya kasance watanni 15.3 (95% CI: 14.2, 16.9) a cikin Pluvicto da BSoC hannu da watanni 11.3 (95% CI: 9.8, 13.5) a cikin hannun BSoC, bi da bi. An iyakance fassarar girman tasirin rPFS saboda babban matakin tantancewa daga farkon faduwa a hannun kulawa.
Abubuwan da suka fi dacewa (≥20%) da ke faruwa a mafi girma a cikin marasa lafiya da ke karbar Pluvicto sune gajiya, bushe baki, tashin zuciya, anemia, rage cin abinci, da maƙarƙashiya. Abubuwan da suka fi dacewa na dakin gwaje-gwaje da suka fi muni daga asali a cikin ≥30% na marasa lafiya da ke karbar Pluvicto sun kasance raguwar lymphocytes, rage haemoglobin, rage leukocytes, rage platelet, rage calcium, da rage sodium. Jiyya tare da Pluvicto na iya haifar da haɗari daga fallasa radiation, myelosuppression, da guba na koda. Tsawon lokacin bin aminci a cikin VISION bai isa ba don kama abubuwan da ke da alaƙa da radiation a ƙarshen.
Adadin Pluvicto da aka ba da shawarar shine 7.4 GBq (200 mCi) a cikin jini kowane mako 6 don har zuwa allurai 6, ko har sai cutar ta ci gaba ko rashin yarda da guba.
View full prescribing information for Pluvicto. View full prescribing information for Locametz.
