Ukwelashwa Okusha Kwe-Advanced Prostate Cancer Kubantu Abadala

I-Accord BioPharma, uphiko olukhethekile lwase-US lwe-Intas Pharmaceuticals, Ltd. igxile ekuthuthukisweni kwe-oncology, i-immunology, kanye nokwelashwa kokunakekelwa okubucayi, imemezele namuhla ukwethulwa kwe-US kwe-CAMCEVI™ (leuprolide) 42mg injection emulsion yokwelapha umdlavuza we-prostate othuthukisiwe kubantu abadala. I-Accord BioPharma iphethe ukusatshalaliswa e-US I-US Food and Drug Administration igunyaze Isicelo Esisha Sezidakamizwa (i-NDA) se-CAMCEVI esivela ku-Foresee Pharmaceuticals ngoMeyi 25, 2021.

I-CAMCEVI iwukwakheka kokuqala okulungele ukujova okungenamagciwane kwe-leuprolide mesylate yomjovo ongaphansi kwesikhumba ofika kusisirinji esigcwaliswe ngaphambili ngaphandle kokuxutshwa okudingekayo. Ocwaningweni oluvulekile, lwengalo eyodwa yabantu abadala abangu-137 abathole u-42mg we-CAMCEVI ngoSuku 0 kanye neVeki lama-24, i-CAMCEVI inikeze ukucindezela okungaguquki kwe-testosterone kumazinga wokuthena ngemva komjovo wokuqala, kusukela Isonto lesi-4 kuya kuViki 48. I-CAMCEVI akufanele isetshenziswe. ezigulini ezine-hypersensitivity ku-GnRH noma i-GnRH analogs ngenxa yokusabela okungenzeka kwe-anaphylactic.1 Ukusabela okungavamile okuvame kakhulu (≥10%) okwenzeka ngesikhathi sokulandelela okuphakathi kwezinsuku ze-336 kwakuyi-flush eshisayo, umfutho wegazi ophakeme, ukusabela kwendawo yomjovo, umgudu wokuphefumula ophezulu. izifo, ubuhlungu be-musculoskeletal, ukukhathala, nobuhlungu ekugcineni.

Iziguli ezifanele ezinqunyelwe i-CAMCEVI zizokwazi ukufinyelela ezinsizeni zokwesekwa, njengezixazululo zosizo lwe-copay yezentengiselwano, izinhlelo zokusiza isiguli, kanye nenombolo yocingo yomtholampilo enabasebenzi abahlengikazi enikeza izimpendulo ezidingeka kakhulu zemibuzo evela ezigulini noma ethimbeni lazo lokunakekela. Lezi zinsizakalo zokusekela iziguli zenzelwe ngokukhethekile ukuhlangabezana nezidingo zenani lethu leziguli, zisiza ukususa izithiyo ekwelapheni kanye nokweseka iziguli kulo lonke uhambo lwazo lokunakekelwa kwezempilo nge-CAMCEVI. Ukuze ufunde kabanzi, vakashela ku-www.camcevihcp.com.

Ukwengeza, i-Accord BioPharma inikeza ochwepheshe bezokunakekelwa kwempilo ukufinyelela ku-AccordConnects™, uhlelo lokusebenza lweselula oluklanyelwe ukusiza izinqubo zokunakekelwa kwezempilo zilawule uhlu lwangaphakathi lwe-CAMCEVI. Uhlelo lokusebenza luvumela izinqubo zokunakekelwa kwempilo ukuskena amabhakhodi ukuze ungene ngokunembile ukubala kokusungula kwe-CAMCEVI, iphrojekthi yezidingo zokusungula zomkhiqizo wesikhathi esizayo, sebenzisa imibiko yesitoko kanye nokusetshenziswa, futhi ivumela ukulandeleka phambili nangemuva ukuze kutholwe umkhiqizo.

"Ukwethulwa kwe-CAMCEVI e-US kukhombisa ukuzibophezela kwethu kokudlulela ngale kwesayensi yezokwelapha, ukubona izifo ngombono wesiguli futhi sithuthukise izindlela zokwelapha ezisezingeni eliphezulu ezithuthukisa isipiliyoni sokwelashwa sisonke," kusho uChrys Kokino, uMongameli we-US BioPharma e-Accord BioPharma.

Ulwazi Olubalulekile Lokuphepha: I-CAMCEVI, njengamanye ama-agonists e-GnRH, ibangela ukwanda kwesikhashana kumazinga e-serum e-testosterone phakathi nesonto lokuqala lokwelashwa okungabangela ukuwohloka kwesikhashana kwezimpawu. Iziguli ezinezilonda ze-metastatic vertebral kanye/noma ezinokuphazamiseka kwendlela yomchamo kufanele zibhekwe eduze phakathi namasonto ambalwa okuqala okwelapha. I-Hyperglycemia kanye nengozi eyengeziwe yokuba nesifo sikashukela kuye kwabikwa emadodeni athola ama-agonists e-GnRH. Izinga le-glucose yegazi kufanele liqashwe futhi lilawulwe ngokuya ngomkhuba wamanje womtholampilo. Ingozi eyengeziwe ye-myocardial infarction, ukufa kwenhliziyo kungazelelwe, kanye nokushaywa unhlangothi kuye kwabikwa ngokuhambisana nokusetshenziswa kwama-agonists e-GnRH. Iziguli kufanele ziqashelwe isifo senhliziyo nemithambo yegazi nangokuhambisana nokusebenza komtholampilo kwamanje. Ukwelashwa kokuncisha i-Androgen kungase kunwebe isikhawu se-QT. Ukudlikizela kubikwe ezigulini ezithola ama-agonists e-GnRH, njenge-CAMCEVI. Gada amazinga e-serum e-testosterone kulandela umjovo we-CAMCEVI. Ngokusekelwe kokutholwe ezifundweni zezilwane kanye nendlela yokwenza, i-CAMCEVI ingabangela ukulimala kwengane lapho inikezwa kwabesifazane abakhulelwe. Okuvame kakhulu (≥10%) ukusabela okungekuhle ngesikhathi sokulandela okumaphakathi kwezinsuku ezingama-336 kwakuwukushisa okushisayo, umfutho wegazi ophakeme, ukusabela kwendawo yomjovo, izifo eziphezulu zepheshana lokuphefumula, ubuhlungu bemisipha namathambo, ukukhathala, nobuhlungu emaphethelweni.