Unyango olutsha lwe-Advanced Prostate Cancer

I-Accord BioPharma ibhengeze namhlanje, ngentsebenziswano ne-Foresee Pharmaceuticals Co., Ltd., ukuphehlelelwa kwe-US kweCAMCEVI™ (leuprolide) 42mg inaliti ye-emulsion yonyango lomhlaza wedlala lesinyi kubantu abadala. I-US Food and Drug Administration ivume iSicelo esitsha seChiza (i-NDA) se-CAMCEVI esivela kwi-Foresee Pharmaceuticals ngomhla wama-25 kuMeyi, 2021. Inaliti ye-CAMCEVI™ 42 mg inelayisensi eyodwa kuphela kwi-Accord BioPharma e-US yokuthengisa.

"Ukuqaliswa kwe-CAMCEVI yase-US kuqinisekisa ukubaluleka kobuchwephesha be-Foresee's Stabilized Injectable Formulation (SIF) ubuvulindlela kwaye linyathelo elibalulekileyo ekufezekiseni umsebenzi wethu wokuphucula umgangatho wokunyamekela," kusho uDkt Ben Chien, umsunguli kunye noSihlalo we-Foresee. Siyazi ukuba i-Accord BioPharma iyabelana kule njongo ibalulekileyo.

I-CAMCEVI yeyokuqala ngqa ukuba ilungele ukutofwa inzala ye-leuprolide mesylate yenaliti engaphantsi kwesikhumba esiza kwisirinji esele ifakwe ngaphambili ngaphandle kokuxubana okufunekayo. Kwileyibhile evulekileyo, isifundo sengalo eyodwa yabantu abadala be-137 abafumana i-42mg ye-CAMCEVI ngoSuku lwe-0 kunye neVeki ye-24, i-CAMCEVI yanikezela ukunyanzeliswa kwe-testosterone eqhubekayo kumanqanaba e-castrate emva kwesitofu sokuqala, ukusuka kwiVeki yesi-4 ukuya kwiVeki ye-48.1 i-CAMCEVI akufanele isetyenziswe izigulane ezine-hypersensitivity kwi-GnRH okanye i-GnRH analogs ngenxa ye-anaphylactic reactions ezinokwenzeka.1 Iimpendulo ezixhaphakileyo eziqhelekileyo (≥10%) ezenzeka ngexesha lokulandelwa kwexesha eliqhelekileyo leentsuku ze-336 zazishushu, i-hypertension, i-injection site reactions, izifo zendlela yokuphefumula ephezulu. , intlungu ye-musculoskeletal, ukudinwa, kunye neentlungu ekupheleni.1

“I-Accord Healthcare ibonelela ngeemveliso zamayeza ezisemgangathweni e-US ukusukela kwiminyaka yoo-2000. Ngobu bambiswano noForesee ekusungulweni kweCAMCEVI, sichulumancile ukuphehlelela ngokusesikweni i-Accord BioPharma egxininise kakhulu kumayeza akhethekileyo, okuya ngaphaya kwebhayoloji ukuzisa ukufikelela ngakumbi kumayeza akumgangatho ophezulu kwizigulana kulo lonke elase-US, ”utshilo uBinish. Chudgar, uSihlalo, i-Accord Healthcare kunye ne-Accord BioPharma.

"Itekhnoloji ye-Foresee ivumela ukuba sinikeze unyango kumhlaza we-prostate ophucukileyo osebenzayo kunye nokulungeleyo kubasebenzi, kunye nesirinji ezaliswe kwangaphambili ibonelela ngamalungiselelo alula akhokelela kumava aphuculweyo onyango kubasebenzi bezempilo," utshilo uChrys Kokino, uMongameli wase-US. I-BioPharma kwi-Accord BioPharma. "I-CAMCEVI iphawula umzekelo obalulekileyo wefilosofi yethu - ukuya ngaphaya kwebhayoloji - isebenza."

Ulwazi oluBalulekileyo loKhuseleko: I-CAMCEVI, njengezinye ii-agonists ze-GnRH, ibangela ukunyuka okwethutyana kumanqanaba e-serum ye-testosterone kwiveki yokuqala yonyango enokubangela ukuba iimpawu zibe zibi nakakhulu. Izigulane ezinezilonda ze-vertebral ze-metastatic kunye / okanye kunye nokuphazamiseka kwendlela yomchamo kufuneka ziqwalaselwe ngokukhawuleza kwiiveki ezimbalwa zokuqala zonyango. I-Hyperglycemia kunye nomngcipheko okhulayo wokuphuhlisa isifo sikashukela kuye kwabikwa kumadoda afumana i-GnRH agonists. Amanqanaba eglucose yegazi kufuneka abekwe esweni kwaye alawulwe ngokwenkqubo yeklinikhi yangoku. Ukunyuka kwengozi ye-myocardial infarction, ukufa kwentliziyo ngokukhawuleza, kunye ne-stroke kuye kwabikwa ngokubambisana nokusetyenziswa kwe-agonists ye-GnRH. Izigulane kufuneka zibekwe iliso kwi-cardiovascular disease kwaye ngokwenkqubo yeklinikhi yangoku. Unyango lokunciphisa i-Androgen lunokwandisa ixesha le-QT. Ukuxhatshazwa kuye kwabikwa kwizigulane ezifumana i-agonists ye-GnRH, njenge-CAMCEVI. Jonga amanqanaba e-serum e-testosterone emva kwesitofu se-CAMCEVI. Ngokusekwe kwiziphumo kwizifundo zezilwanyana kunye nendlela yokwenza, i-CAMCEVI inokubangela ingozi yomntwana xa ilawulwa kwabasetyhini abakhulelweyo. Ezona zixhaphakileyo (≥10%) ukusabela okungalunganga ngexesha lokulandelelwa okuphakathi kweentsuku ezingama-336 zazishushu, uxinezeleko lwegazi, ukuchaneka kwendawo yokutofa, usulelo lwendlela yokuphefumula ephezulu, iintlungu ze-musculoskeletal, ukudinwa, kunye neentlungu eziphelweni.