Ukwelashwa Okusha Kwe-Advanced Prostate Cancer

I-Accord BioPharma imemezele namuhla, ngokubambisana ne-Foresee Pharmaceuticals Co., Ltd., ukwethulwa kwe-US kwe-CAMCEVI™ (leuprolide) 42mg umjovo womjovo we-emulsion wokwelapha umdlavuza we-prostate osezingeni eliphezulu kubantu abadala. I-US Food and Drug Administration igunyaze I-New Drug Application (NDA) ye-CAMCEVI evela ku-Foresee Pharmaceuticals ngomhla ka-May 25, 2021. Umjovo we-CAMCEVI™ 42 mg unikezwe ilayisense ngokukhethekile ku-Accord BioPharma e-US ukuze udayiswe.

"Ukwethulwa kwe-CAMCEVI e-US kuqinisekisa ukubaluleka kobuchwepheshe be-Foresee bokuphayona obuzinzile bokusungula i-Stabilized Injectable Formulation (SIF) futhi kuyisinyathelo esikhulu sokufeza umgomo wethu wokuthuthukisa izinga lokunakekelwa," kusho uDkt. Ben Chien, umsunguli kanye noSihlalo we-Foresee. "Siyazi ukuthi i-Accord BioPharma iyahlanganyela kulowo mgomo obalulekile."

I-CAMCEVI iwukwakheka kokuqala okulungele ukujova okungenamagciwane kwe-leuprolide mesylate yomjovo ongaphansi kwesikhumba ofika kusipetu esigcwaliswe ngaphambili ngaphandle kokuxutshwa okudingekayo. Ocwaningweni oluvulekile, olwenziwa ngengalo eyodwa lwabantu 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 Isonto 48.1 i-CAMCEVI akufanele isetshenziswe iziguli 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 ophezulu, ukusabela kwendawo yomjovo, izifo eziphezulu zokuphefumula. , ubuhlungu be-musculoskeletal, ukukhathala, nobuhlungu ekugcineni.1

“I-Accord Healthcare ibihlinzeka ngemikhiqizo yemithi esezingeni eliphezulu e-US kusukela ekuqaleni kwawo-2000. Ngalobu budlelwano noForesee lapho kwethulwa i-CAMCEVI, sijabule ukwethula ngokusemthethweni i-Accord BioPharma egxile kakhulu emithini ekhethekile yemithi, ezodlulela ngalé kwesayensi yezinto eziphilayo ukuze ilethe ukufinyelela okwengeziwe emithini yekhwalithi ephezulu ezigulini kulo lonke elase-US,” kusho u-Binish. Chudgar, uSihlalo, i-Accord Healthcare kanye ne-Accord BioPharma.

"Ubuchwepheshe be-Foresee busivumela ukuthi sinikeze ukwelashwa komdlavuza we-prostate osezingeni eliphezulu osebenza kahle futhi olungele odokotela, ngesipetu esigcwaliswe ngaphambili esihlinzeka ngokulungiselela okulula okuholela ekuhlangenwe nakho kokwelashwa okuthuthukisiwe kochwepheshe bezempilo," kusho uChrys Kokino, uMongameli wase-US. I-BioPharma ku-Accord BioPharma. "I-CAMCEVI imaka isibonelo esibalulekile sefilosofi yethu - edlula isayensi yezinto eziphilayo - esenzweni."

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.