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Ukwelashwa kokuhlanganiswa komdlavuza wesibindi seRoche PD-1 inhibitor yi-FDA njengokwelashwa okuphumelelayo

Yabelana ngalokhu okuthunyelwe

I-Swiss Roche Group imemezele izolo lokho I-TECENTRIQ® (atezolizumab) kuhlanganiswe ne-Avastin® (bevacizumab) kuvunywe yi-US Food and Drug Administration (FDA) ukuze kutholakale ukwelashwa okuphumelelayo kokwelashwa kokuqala (komugqa wokuqala) kwesibindi esithuthukile noma esine-metastatic Iziguli ezine-cell carcinoma (HCC).

I-HCC uhlobo oluvame kakhulu lwamabanga aphansi umdlavuza wesibindi . Lokhu kwelashwa okuphumelelayo kusekelwe emiphumeleni yocwaningo lweSigaba Ib ngokuphepha nomsebenzi womtholampilo we-TECENTRIQ kuhlanganiswe ne-Avastin.

UDkt Sandra Horning, isikhulu sezokwelapha eRoche nenhloko yezokuthuthukiswa komkhiqizo womhlaba jikelele, uthe: I-Hepatocellular carcinoma, njengesimila esibi, inezindlela zokwelashwa ezilinganiselwe futhi iyimbangela ehamba phambili yokufa emhlabeni wonke. Imininingwane yokuqala yokwelashwa kwalesi sifo nge-TECENTRIQ ne-Avastin iyathembisa. Sibheke phambili ekusebenzisaneni nomnyango wezempilo ukuletha lolu hlelo lokwelashwa oluthembisayo kakhulu ezigulini ezine-hepatocellular carcinoma ngokushesha okukhulu.

I-Breakthrough Therapy Designation (BTD) ihlose ukusheshisa ukuthuthukiswa kanye nokubuyekezwa kwemithi emisha yokwelashwa kwezifo ezibucayi noma ezisongela impilo ukuze kuqinisekiswe ukuthi le mishanguzo ivunywa yi-FDA ngokushesha okukhulu ukuze izuze iziguli. Le akuyona i-BTD yama-22 kuphela etholwe ngumugqa womkhiqizo wemikhiqizo kaRoche, kodwa futhi ne-3 BTD etholwe yi-TECENTRIQ.

I-Roche Group ishicilele imininingwane evela ocwaningweni lweSigaba Ib se-hepatocellular carcinoma emhlanganweni waminyaka yonke we-American Society of Clinical Oncology (ASCO) ngoJuni 2018. Imiphumela yocwaningo ikhombise ukuthi ngemuva kokulandelwa okuphakathi kwezinyanga eziyi-10.3, ukuxolelwa kwabonwa ku I-15 (65%) yeziguli ezingama-23 ezivivinywayo.

Ngemva kokulandelela okumaphakathi kwezinyanga ezingu-10.3, ukusinda kwe-median progression-free survival (PFS), ubude besikhathi sokuxolelwa (DOR), isikhathi sokuqhubekela phambili kwesifo (TTP), kanye nokusinda jikelele (OS) akuzange kufinyelelwe. Ezigulini ezihlolwa ngokuphepha (n = 43), i-28% (n = 12) yabhekana nezenzakalo ezimbi ezihlobene nokwelashwa kwebanga lesi-3-4, futhi azikho izehlakalo ezimbi ezihlobene nokwelashwa zebanga lesi-5 ezabonwa.

URoche unikeze ngemininingwane eyengeziwe ngokuya ngezidingo ze-FDA, futhi unikezwe iziqu zokwelashwa okuthuthukile. Ngemuva kokuthola imininingwane ebuyekeziwe kusuka ekuhlolweni kokulandela, uRoche uzoshicilela imiphumela yocwaningo engqungqutheleni yezokwelapha yesikhathi esizayo.

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