I-FDA ivuma iFotivda Yomdlavuza Wezinso

I-AVEO Oncology (Nasdaq: AVEO) namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) ivume i-FOTIVDA^® (i-tivozanib) yokwelashwa kwabantu abadala abane-renal cell carcinoma (RCC) ebuyele emuva noma ephikisayo abathola izindlela zokwelashwa ezimbili noma ngaphezulu zangaphambilini. I-FOTIVDA i-oral, isizukulwane esilandelayo se-vasot endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI).

"Ukwamukelwa kwanamuhla kwe-FOTIVDA kunikeza ithuluzi elisha lokwelapha iziguli ezinomdlavuza wezinso ezibuyele emuva noma ezingasenakho ukwelashwa okuyizindlela ezimbili noma ngaphezulu," kusho uBrian Rini, MD, oyiChief of Clinical Trials eVanderbilt Ingram Cancer Center nomphenyi omkhulu we Isivivinyo se-TIVO-3. 

“Ngokuthuthuka ekwelashweni kwe-RCC, iziguli ziphila isikhathi eside, zandisa isidingo sezindlela zokwelashwa ezifakazelwe, ezibekezeleleke kahle esimweni esibuyele emuva noma esiphikisayo. Ucwaningo lwe-TIVO-3 lucwaningo lokuqala oluhle lweSigaba 3 ezigulini ze-RCC ezathola izindlela zokwelashwa ezimbili noma ngaphezulu zangaphambilini, kanye nesifundo sokuqala seSigaba 3 RCC ukufaka inani labantu elichazwe ngaphambilini leziguli ezithole i-immunotherapy yangaphambilini, izinga lokunakekelwa lamanje ekwelashweni komugqa wangaphambilini. Ngalesi sigunyazo, ngikholwa ukuthi i-FOTIVDA imele ukungenelela okuhehayo, futhi ngilindele ukuthi idlale indima ebonakalayo ekwakhiweni kwendawo yokwelashwa kwe-RCC. ”

"Sikholelwa emandleni e-FOTIVDA ukuhlinzeka ngenketho yokwelashwa ehlukanisiwe yenani elikhulayo labantu e-US abane-RCC ebuyela emuva noma ephikisayo, futhi namuhla kuphawula ukuphela kweminyaka eminingi yokusebenza kanzima nokuzimisela kwabantu abaningi ukuletha le ndlela yokwelapha ezigulini, ”Kusho uMichael Bailey, umengameli nesikhulu esiphezulu se-AVEO. “Ngokuvunyelwa kwanamuhla, i-AVEO iqala uhambo lwayo njengenkampani esesigabeni sokuhweba, impumelelo ephawulekayo embonini yethu. Egameni lalo lonke iqembu le-AVEO, ngithanda ukubonga zonke iziguli, imindeni yazo, kanye nabanakekeli abazikhandlile ngokuzikhandla okwenza lolu suku lube nokwenzeka. ”

"I-RCC ebuyiselwe emuva noma ephikisayo iyisifo esibuhlungu lapho imiphumela yesiguli ingakhawulelwa ngenxa yokuhweba phakathi kokubekezelelana nokusebenza kahle," kusho uDena Battle, umongameli weKCCure. "Ukwamukelwa yi-FDA kwe-FOTIVDA kubonisa intuthuko ejabulisayo nenenjongo ngokunikeza indlela yokwelashwa entsha yalesi siguli."

I-AVEO ihlela ukwenza i-FOTIVDA itholakale ezigulini ezise-US ngoMashi 31, 2021.

Ukuvunywa kwe-FOTIVDA kususelwa ocwaningweni olubaluleke kakhulu lwe-AVEO lweSigaba 3, i-TIVO-3, ngokuqhathanisa i-FOTIVDA ne-sorafenib ku-RCC ebuyile noma ephikisayo elandela izindlela zokwelashwa ezimbili noma ngaphezulu zangaphambilini. Isicelo sisekelwa futhi yizilingo ezintathu ezengeziwe ku-RCC futhi sifaka imininingwane yezokuphepha kusuka ezifundweni zezilingo ezingaphezu kuka-1,000 XNUMX zomtholampilo.

Iziguli (n = 350) ezibhalise ocwaningweni lwe-TIVO-3 zenziwa ngokungahleliwe i-1: 1 ukuthola i-FOTIVDA noma i-sorafenib. Umphumela oyinhloko wokusebenza kahle kwaba ukusinda okungenazinqubekela phambili (PFS), kuhlolwe yikomidi elizimele lokuhlola i-radiology. Amanye amaphuzu wokusebenza kahle ukusinda okuphelele (i-OS) nezinga lokuphendula ngenhloso (ORR).

IMedian PFS kwakuyizinyanga eziyi-5.6 (95% CI: 4.8, 7.3) engalweni yeFOTIVDA (n = 175) uma kuqhathaniswa nezinyanga eziyi-3.9 (95% CI: 3.7, 5.6) kulabo abaphathwa nge-sorafenib (HR 0.73; 95% CI: 0.56 , 0.95; p = 0.016). IMedian OS yayingu-16.4 (95% CI: 13.4, 21.9) nezinyanga eziyi-19.2 (95% CI: 14.9, 24.2), yezingalo ze-FOTIVDA ne-sorafenib, ngokulandelana (HR 0.97; 95% CI: 0.75, 1.24). I-ORR yayingu-18% (95% CI: 12%, 24%) engalweni ye-FOTIVDA no-8% (95% CI: 4%, 13%) engalweni ye-sorafenib.

Ukuphendula okuvame kakhulu (≥20%) kwakuwukukhathala, umfutho wegazi ophakeme, isifo sohudo, ukuncipha kokudla, isicanucanu, i-dysphonia, i-hypothyroidism, ukukhwehlela, ne-stomatitis. Ukungajwayelekile kwelebhu 3 noma 4 kwelabhorethri (≥5%) kwehliswe i-sodium, kwanda i-lipase, kwehla ne-phosphate.

Umthamo we-tivozanib onconywayo ngu-1.34 mg kanye ngosuku noma ngaphandle kokudla izinsuku ezingama-21 njalo ezinsukwini ezingama-28 ekwelashweni okulandelwa yizinsuku eziyi-7 ekwelashweni (umjikelezo wezinsuku ezingama-28) kuze kube ukuqhubekela phambili kwesifo noma ubuthi obungamukeleki.

Ucingo Lenkomfa kanye Nemininingwane Ye-Webcast

Ngokuphathelene nalesi simemezelo, i-AVEO izosingatha ikholi yengqungquthela kanye ne-slide webcast namuhla, Mashi 10, 2021, ngo-6: 00 PM Isikhathi saseMpumalanga. Ucingo lungatholakala ngokushayela (844) 882-7841 (e-US naseCanada) noma (574) 990-9828 (wamazwe omhlaba). Iphasikhodi yocingo lwenkomfa ingu-4648498. Ukuthola i-webcast ebukhoma kanye nesethulo esihambisana naso, noma okurekhodiwe okulandelayo okugciniwe, sicela uvakashele isigaba sabatshalizimali sewebhusayithi ye-AVEO ku www., kulei.com. I-webcast izorekhodwa futhi itholakalele ukuphindwa kwiwebhusayithi ye-AVEO amasonto amabili.

Mayelana FOTIVDA^® (izwi)

KU-FOTIV^® (i-tivozanib) i-oral, isizukulwane esilandelayo se-vascular endothelial growth factor receptor (VEGFR) i-tyrosine kinase inhibitor (TKI). Kuyi-inhibitor enamandla, ekhethiwe ye-VEGFRs 1, 2, kanye ne-3 enesigamu sempilo ende eklanyelwe ukuthuthukisa ukusebenza kahle nokubekezelelana. I-AVEO ithole imvume ye-US Food and Drug Administration (FDA) ye-FOTIVDA ngoMashi 10, 2021 yokwelashwa kweziguli ezikhulile ezibuyelwe ukuchachamba noma ezithuthukisiwe. I-renal cell carcinoma (RCC) kulandela izindlela zokwelapha ezimbili noma ngaphezulu ze-systemic zangaphambili. I-FOTIVDA yavunywa ngo-Agasti 2017 ku-European Union nakwamanye amazwe asendaweni yozakwethu i-EUSA Pharma (UK) Limited yokwelapha iziguli ezikhulile ezine-RCC ethuthukisiwe. I-FOTIVDA ikhonjiswe ukunciphisa kakhulu ukukhiqizwa kwe-T-cell elawulayo kumamodeli angaphambi komtholampilo¹. I-FOTIVDA itholwe nguKyowa Kirin.

INDICATIONS

I-FOTIVDA ikhonjisiwe ekwelapheni iziguli ezindala ezine-renal cell carcinoma (RCC) ebuye yaphinde yabuyela emuva noma yaphinde yalandela ngemuva kwezindlela zokwelashwa ezimbili noma ngaphezulu zangaphambilini.

ULWAZI OLUBALULEKILE LOKUPHEPHA

IZIXWAYISO NEZINYATHELO

Umfutho wegazi ophezulu kanye ne-Hypertensive Lawula umfutho wegazi ngaphambi kokuqala i-FOTIVDA. Gada umfutho wegazi ophezulu bese welapha njengoba kudingeka. Ngokuphikelela komfutho wegazi ophakeme naphezu kokusetshenziswa kwemithi elwa nomfutho wegazi ophezulu, yehlisa umthamo we-FOTIVDA.

Ukwehluleka Kwenhliziyo: Ukuqapha izimpawu noma izimpawu zokwehluleka kwenhliziyo kulo lonke ukwelashwa nge-FOTIVDA.

I-Cardiac Ischemia ne-Arterial Thromboembolic Imicimbi: Bhekisisa iziguli ezisengozini enkulu yale micimbi. Yiyeke unomphela i-FOTIVDA ngemicimbi ye-arterial thromboembolic, efana ne-myocardial infarction kanye ne-stroke.

Imicimbi ye-Venous Thromboembolic: Bhekisisa iziguli ezisengozini enkulu yale micimbi. Yiyeke unomphela i-FOTIVDA ngemicimbi emibi kakhulu ye-venous thromboembolic.

Imicimbi Ye-hemorrhagic: Bheka eduze iziguli ezisengozini noma ezinomlando wokopha.

I-Proteinuria: Gada kulo lonke ukwelashwa nge-FOTIVDA. Ukuze uthole i-proteinuria elinganiselayo noma ebucayi, yehlisa umthamo noma uphazamise ukwelashwa nge-FOTIVDA okwesikhashana.

Ukungasebenzi Kwe-thyroid Qapha ngaphambi kokuqala futhi kulo lonke ukwelashwa nge-FOTIVDA.

Ubungozi Bokupholisa Ukulimala Kokulimala: Vimba i-FOTIVDA okungenani izinsuku ezingama-24 ngaphambi kokuhlinzwa kokukhetha. Musa ukuphatha okungenani amasonto ama-2 ngemuva kokuhlinzwa okukhulu nokuphulukiswa okwanele kwenxeba. Ukuphepha kokuqalisa kabusha kwe-FOTIVDA ngemuva kokuxazululwa kwezinkinga zokuphulukiswa kwesilonda akukasungulwa.

Ukubuyiselwa emuva kwe-Leukoencephalopathy Syndrome (RPLS): Yeka i-FOTIVDA uma izimpawu noma izimpawu ze-RPLS zenzeka.

Ubuthi be-Embryo-Fetal: Kungadala ukulimala kwesisu. Ukweluleka iziguli ngobungozi obungase bube khona kumbungu nokuthi zisebenzise izindlela zokuvimbela inzalo ngempumelelo.

Ukusabela Okwe-Allergic ku-Tartrazine: I-0.89 mg capsule ye-FOTIVDA iqukethe i-FD & C Yellow No 5 (tartrazine) engadala ukusabela kohlobo lokungezwani komzimba (kubandakanya i-asthma ye-bronchial) kwezinye iziguli ezithintekayo.

IZIPHENDULO EZIKHULULEKILE

Ukuphendula okuvame kakhulu (≥20%) kwakuwukukhathala, umfutho wegazi ophakeme, isifo sohudo, ukuncipha kwesifiso sokudla, isicanucanu, i-dysphonia, i-hypothyroidism, ukukhwehlela, ne-stomatitis, kanye nokungajwayelekile kwelebhu oku-3 noma kwe-4 kwelabhorethri (≥5%) kwehle nge-sodium, lipase lenyuka, nephosphate yehla.

UKUXHUMANA NEZIDAKAMIZWA

Ama-Inducers aqinile we-CYP3A4: Gwema ukuphathwa kwe-FOTIVDA ngama-inducers aqinile we-CYP3A4.

SEBENZISA ABANTU ABAKHETHEKILE

Ukumisa: Yala ukuthi ungancelisi ibele.
Abesifazane nabesilisa abanamandla okuzala: Kungalimaza ukuzala.
Ukukhubazeka kwe-Hepatic: Lungisa isilinganiso kwiziguli ezinokukhubazeka okulinganiselwe kwe-hepatic. Gwema ukusetshenziswa kweziguli ezinokukhubazeka okukhulu kwe-hepatic.

Ukubika IZIMPENDULO ZESIKHATHI ESIKHULULEKILE, xhumana ne-AVEO Pharmaceuticals, Inc. ku-1-833-FOTIVDA (1-833-368-4832) noma i-FDA ku-1-800-FDA-1088 noma www.fda.gov/iswatch.

Sicela ubheke i-FOTIVDA Full Prescribing Information etholakala ku- www.AVEOoncology.com.

Mayelana ne-Advanced Renal Cell Carcinoma

Ngokwezibalo ze-American Cancer Society ka-2021, i-renal cell carcinoma (RCC) uhlobo oluvame kakhulu lomdlavuza wezinso, ophakathi kwemidlavuza eyishumi ejwayelekile kwabesilisa nabesifazane. Cishe zingama-73,750 izigameko ezintsha zomdlavuza wezinso ezizotholakala minyaka yonke kanti ngabantu ababalelwa ku-14,830 abazobulawa yilesi sifo. Ezigulini ezinesifo sekwephuzile, izinga lokusinda kweminyaka emihlanu lingu-13%. Ama-ejenti akhombe indlela ye-vascular endothelial growth factor (VEGF) akhombise umsebenzi obalulekile we-antitumor ku-RCC.² Ngokusho kokushicilelwa kwe-2019, ama-50% eziguli ezingaba ngu-10,000 XNUMX ezithuthuka zilandela imigqa emibili noma ngaphezulu yokwelashwa zikhetha ukungalutholi olunye ukwelashwa,³ okungabangelwa ukukhathazeka kokubekezelela kanye nokuntuleka kwedatha ukusekela izinqumo zokwelashwa ezisekelwe ebufakazini kulesi siguli esibuyele emuva kakhulu noma esiphikisayo.

Mayelana ne-AVEO Pharmaceuticals, Inc.

I-AVEO yinkampani egxile kwi-oncology egxile kwi-biopharmaceutical ezinikele ekulethweni kwemithi enikeza impilo engcono yeziguli ezinomdlavuza. Isu le-AVEO ukugxila kwizinsizakusebenza zalo ekuthuthukiseni nasekuthengiseni abathengi balo mkhiqizo eNyakatho Melika, ngenkathi kuqhutshwa ubambiswano ukuxhasa ukuthuthukiswa kanye nokuhweba kwamanye ama-geographies. Umuntu ohola phambili we-AVEO, uFOTIVDA^® (tivozanib), ithole imvume ye-US Food and Drug Administration (FDA) ngoMashi 10, 2021 yokwelashwa kweziguli ezindala ezine-renal cell carcinoma (RCC) ebuye yaphinde yabuyela emuva noma yalandela kulandela izindlela zokwelashwa ezimbili noma ngaphezulu zangaphambilini. FOTIVDA^® yamukelwa ngo-Agasti 2017 e-European Union nakwamanye amazwe asendaweni ye-EUSA yokwelashwa kweziguli ezindala ezine-RCC esezingeni eliphezulu. I-AVEO ngaphambilini ibike idatha ethembisayo yokuqala yomtholampilo ku-ficlatuzumab (anti-HGF IgG1 mAb) emdlavuzeni wekhanda nentamo, umdlavuza we-pancreatic kanye ne-acute myeloid leukemia futhi iqhuba isilingo somtholampilo esiqinisekisayo sesiGaba 2 se-ficlatuzumab sokwelashwa okungenzeka komdlavuza wekhanda nentamo . Iphayiphi le-AVEO labaqokelwe umkhiqizo lifaka ne-AV-380 (anti-GDF15 IgG1 mAb). I-AVEO ngaphambilini ibike ukwamukelwa kwesicelo sayo esisha sokuphenya e-US se-AV-380 kanye nokuqaliswa kwayo kwesivivinyo somtholampilo weSigaba 1 sokwelapha okungaba khona komdlavuza we-cachexia. Iphayiphi lesigaba sangaphambilini se-AVEO lifaka ama-antibody monoclonal ekuthuthukiseni i-oncology, kufaka phakathi i-AV-203 (anti-ErbB3 mAb) ne-AV-353 (anti-Notch 3 mAb). I-AVEO izibophezele ekwakheni indawo yokwehlukahlukana nokufakwa.

Isaziso Sokuxwayisa Mayelana Nezitatimende Zokufuna Phambili

Lokhu kukhishwa kwabezindaba kuqukethe izitatimende ezibheke phambili ze-AVEO ngaphakathi kwencazelo yoMthetho Wezokulondolozwa Kwezimvume Zobunikazi wangonyaka we-1995 ezibandakanya ubungozi obukhulu nokungaqiniseki. 

Zonke izitatimende, ngaphandle kwezitatimende zeqiniso lomlando, eziqukethwe kulokhu kukhishwa kwezitatimende izitatimende ezibheke phambili. Amagama athi “lindela,” “kholwa,” “lindela,” “themba,” “hlosela,” “angahle,” “ahlele,” “amandla,” “anga,” “kufanele,” “anga,” “afune,” “Bheka phambili,” “phambili,” “umgomo,” “isu,” noma okuphambene kwalawa magama noma ezinye izinkulumo ezifanayo, kuhloselwe ukukhomba izitatimende ezibheke phambili, yize kungezona zonke izitatimende ezibheke phambili eziqukethe lawa magama. 

Lezi zitatimende ezibheke phambili zifaka phakathi kokunye, izitatimende ezimayelana nesikhathi esihleliwe se-AVEO sokwenza i-FOTIVDA itholakale ezigulini zase-US; amandla we-FOTIVDA njengenketho yokwelashwa kweziguli ezine-RCC ebuyile / ephikisayo noma esezingeni eliphakeme; ukusebenza okungenzeka, ukuphepha nokubekezelela i-FOTIVDA, kokubili njengomuntu ozimele ozimele futhi ohlangene ne-immunotherapy; Ukwenziwa kwe-AVEO kwecebo layo lomtholampilo nokulawula i-FOTIVDA; Izinhlelo namasu we-AVEO ezilingweni zamanje nezesikhathi esizayo zokwelashwa kwe-FOTIVDA, ficlatuzumab ne-AV-380 kanye nokuthengiswa kwe-FOTIVDA e-United States; ukuthuthukiswa kwepayipi le-AVEO, kufaka phakathi ukuthuthukiswa kwe-ficlatuzumab ezifundweni eziningi zemitholampilo; ukusebenza okungaba namandla, ukuphepha nokubekezelela i-ficlatuzumab, kokubili njengomuntu ozimele yedwa futhi ohlangene nezinye izindlela zokwelapha; imiphumela engaba khona evela ezifundweni ze-ficlatuzumab yokunikeza i-AVEO ngamathuba okulandela amasu wokulawula; usizo lomtholampilo olungaba khona lwe-ficlatuzumab ezindaweni ezinesidingo esingagcwaliseki; necebo, amathemba, amapulani kanye nezinhloso ze-AVEO zabaqokelwe umkhiqizo wabo kanye neNkampani ngokuvamile. 

I-AVEO isusele okulindelwe nezilinganiso zayo ekucabangeni okungabonisa ukuthi akulungile. Ngenxa yalokhu, abafundi bayaxwayiswa ukuthi bangabeki ukuthembela okungafanele kulokhu okulindelwe kanye nokulinganisa. 

Imiphumela yangempela noma imicimbi ingahluka ngokwezinto ezibonakalayo ezinhlelweni, izinhloso kanye nokulindelwe okudalulwe ezitatimendeni ezibheke phambili ezenziwa yi-AVEO ngenxa yezici ezithile ezibalulekile, kufaka phakathi ubungozi obuhlobene: nekhono le-AVEO lokusebenzisa ngempumelelo amasu alo, kufaka phakathi amandla alo ukuthengisa ngempumelelo i-FOTIVDA nokuthola nokugcina imakethe nokwamukelwa kwabakhokhi besithathu kwe-FOTIVDA; Amandla we-AVEO wokuqongelela izimali ezengeziwe ezidingekayo ukuthengisa ngempumelelo i-FOTIVDA; Ikhono le-AVEO, kanye nekhono labanamalayisense abo, ukukhombisa ukwaneliseka kwezinhlaka ezisebenza ngokomthetho ezifana ne-FDA ukuphepha, ukusebenza kahle kanye nokuzuza okunempilo emtholampilo kwabaqokelwe umkhiqizo we-AVEO, nezingozi eziphathelene nesikhathi nezindleko zokufuna nokuthola ukugunyazwa kokulawulwa ; Ukuthembela kwe-AVEO kubathengisi abavela eceleni ekwakhiweni, ekwenziweni nasekunikezelweni kwe-FOTIVDA kanye nabazongenela umkhiqizo wayo; Ikhono le-AVEO lokungena nokugcina izivumelwano zokubambisana nezamalayisense, kanye nekhono lalo, kanye nekhono labalingani balo abanamasu, ukufeza izinjongo zentuthuko nezentengiselwano ngaphansi kwalezi zinhlelo; Ama-AVEO kanye nekhono lababambisene nabo lokubhalisa ngempumelelo nokuqedela izivivinyo zokwelashwa; Amandla we-AVEO wokugcina ukuhambisana nezimfuneko zokulawula ezisebenza ku-FOTIVDA nakubathengi bayo bomkhiqizo; Amandla we-AVEO okuthola nokugcina ukuvikeleka okwanele kwamalungelo empahla yengqondo aphathelene ne-FOTIVDA kanye nabazongenela umkhiqizo wayo; izidingo zemali engakahlelwa; ukungaqiniseki okuhlobene nekhono le-AVEO lokuthola ukubolekwa okuzayo ngaphansi kwesikhungo semalimboleko seHercules, okuvula ukufezekiswa kwezinyathelo ezihlobene nokuvunywa nokuthengiswa kwe-FOTIVDA e-US; izimo ezingezinhle zomnotho, ezepolitiki nezimboni; imiphumela emibi engahle ibangelwe ubhadane lwe-COVID-19 ekuqhubekeni kwebhizinisi kwe-AVEO, isimo sezezimali, imiphumela yokusebenza, ukwenziwa kwemali kanye namandla okubhalisa ngempumelelo nangesikhathi esifanele, ukuqedela nokufunda idatha kusuka ezivivinyweni zayo zokwelashwa; izici zokuncintisana; kanye nalezo zingcuphe okukhulunywe ngazo ezigabeni ezinesihloko esithi "Izingozi Zobungozi" kanye "Nengxoxo Nokuhlaziywa Kwesimo Sezimali kanye Nemiphumela Yokusebenza - Uketshezi Nezinsizakusebenza Zemali" kufakwe emibikweni yekota kanye neyonyaka ye-AVEO efayeleni ne-Securities and Exchange Commission (SEC) kanye kokunye ukufakwa okwenziwa yi-AVEO nge-SEC. 

Izitatimende ezibheke phambili kulokhu kukhishwa kwezindaba zimelela imibono ye-AVEO kusukela ngosuku lokukhishwa kwabezindaba, futhi imicimbi elandelayo nentuthuko kungadala ukuthi imibono yayo iguquke. 

Ngenkathi i-AVEO ingakhetha ukuvuselela lezi zitatimende ezibheke phambili esikhathini esithile ngokuzayo, ikhipha ngokuqondile noma yisiphi isibopho sokwenza kanjalo. Ngakho-ke, akufanele uthembele kulezi zitatimende ezibheke phambili njengezimele imibono ye-AVEO njenganoma yiluphi olunye usuku ngaphandle kwalolu suku lokukhishwa kwabezindaba.

Noma yikuphi ukubhekiswa kukheli lewebhusayithi le-AVEO kulokhu kukhishwa kwabezindaba kuhloswe ukuthi kube yinkomba engasebenzi yombhalo kuphela hhayi isixhumanisi esisebenzayo.

References:

1. UPawlowski N et al. I-AACR 2013. Iphosta 3971
2. J Angulo no-O Shapiro, Cancers (Basel) 2019 Sep; 11 (9): 1227. [10.3390 / umdlavuza11091227]
3. Izinsizakusebenza Zezinqumo. Isimo se-RCC nesibikezelo. Disemba 12, 2019.