E-Australia malunga nama-2,400 abantu bafunyaniswa ngonyaka ngamnye abane-myeloma (MM), kwaye malunga ne-20,000 yezigulane ezihlala ne-MM nangaliphi na ixesha. Ngelishwa, ngaphezulu kwe-1000 yezigulane ziya kubhubha kolu hlobo lomhlaza wegazi kuwo nawuphi na unyaka kwaye ke ngoko iindlela zonyango olutsha olufana neXPOVIO® ziyafuneka.
I-Antengene Corporation Limited namhlanje yazisa ukuba i-Therapeutic Goods Administration (TGA) yeSebe lezeMpilo lase-Australia libhalise i-XPOVIO® (selinexor) ngezibonakaliso ezimbini: (1) Ngokudibanisa ne-bortezomib kunye ne-dexamethasone (XBd) yokunyanga izigulane zabantu abadala kunye i-myeloma emininzi (MM) abaye bafumana ubuncinane unyango olunye lwangaphambili kunye (2) ngokudibanisa ne-dexamethasone (Xd) kunyango lwezigulane zabantu abadala abane-myeloma ephindaphindiweyo kunye / okanye e-refractory multiple myeloma (R / R MM) abaye bafumana ubuncinane abathathu. amayeza angaphambili kwaye esi sifo sichasa ubuncinci kwi-proteasome inhibitor (PI), ubuncinci imveliso enye ye-immunomodulatory medicinal (IMiD), kunye ne-anti-CD38 monoclonal antibody (mAb).
I-XPOVIO® yeyokuqala kunye nekuphela kwe-SINE evunywe yi-TGA enceda ekubuyiseleni iindlela zokucinezela ithumba emzimbeni.
Unjingalwazi u-Hang Quach, i-Haematologist kwiSibhedlele sase-St Vincent, eMelbourne, uthe, “Ndibe nenyhweba yokuba ngomnye wabaphandi kuphononongo lwezonyango lwase-BOSTON kwaye ukususela ngoko ndiye ndabhala kunye kumaphepha ambalwa erejimeni ye-XBd. Le rejimeni ye-triplet ngokungathandabuzekiyo engqondweni yam phakathi konyango olusebenzayo lokuphinda ubuyele kwixesha le-lenalidomide refractoriness. Kuhlalutyo lweseti, le rejimeni ye-triplet iyasebenza kungakhathaliseki ubudala, izigulane ezibuthathaka okanye ezingekho buthathaka kwaye iyasebenza kwizigulane ezinokukhutshwa okuphantsi kwe-creatinine. Okubalulekileyo, indibaniselwano ye-XBd yayisebenza ngokukodwa kwizigulane ezinomngcipheko ophezulu we-cytogenetics.
Unjingalwazi u-Hang Quach uqhube wathi: "Ndikholelwa ukuba iindlela ezintathu zokuqala zonyango lwe-MM zezona zibalulekileyo ekuchazeni ukusinda kwesigulane ngenxa yokuba uninzi lwezigulane ezine-MM kwimeko yelizwe lokwenyani aziyi kuphila ukubona umgca wesine wonyango okanye ngaphaya. Ngaphezu koko, olona ncedo lukhulu lwezonyango lufunyanwa xa unyango olusebenzayo lusetyenziswa ekubuyeleni komgca wokuqala. Kubalulekile ke ngoko ukuba ugqirha anikwe ukhetho olwaneleyo kweso sithuba “somgca omnye ukuya kwezintathu zangaphambili” ukuvumela eyona rejimeni ifanelekileyo ukuba isetyenziswe ngokusekwe kwiprofayili yesigulana. Ukunqongophala kokhetho olwaneleyo kwizigulane ezine-lenalidomide-refractory ekubuyeleni komgca wokuqala we-MM yindawo yesidingo esingafezekanga e-Australia. Ukufumaneka kwe-XPOVIO®, i-bortezomib kunye ne-dexamethasone njengendlela yokukhetha kule ndawo iya kujongana nale mfuno engafanelekanga.
“EOstreliya, enye indawo ebaluleke kakhulu yemfuno engafezekiyo yezigulana ezine-myeloma kukunqongophala konyango olusebenzayo kwizigulana ezine-triple-class refractory, echasene ne-proteasome inhibitor, ichiza le-immunomodulatory kunye ne-anti-CD38 monoclonal antibody. Inzuzo ye-XPOVIO® kukuba lichiza lomlomo elinesixhobo sokwenza inoveli ngokupheleleyo elenza ukuba lilungele izigulana ezine-triple-class refractory. I-XPOVIO® inokuvelisa iimpendulo kwaye yandise ubomi ngendlela enentsingiselo yeklinikhi ”, utshilo uNjingalwazi u-Andrew Spencer, ugqirha weHaematologist, iSibhedlele sase-Alfred, eMelbourne.
UHayley Beer, i-Interim Co-CEO yaseMyeloma eOstreliya, uthe “Kubaluleke kakhulu ukuba nolunye ukhetho lonyango lwabantu abaphila ne-myeloma eninzi, kunyango lwangaphambili nasemva koko. I-XPOVIO® luhlobo olutsha lwechiza olunendlela yokusebenza ekhethekileyo, ngoko ke oko kuthetha ukuba izigulana zinokuzama indibaniselwano entsha ngaphandle kokuphinda zisebenzise uhlobo lwechiza olwalusetyenziswa ngaphambili.”
“Eli linyathelo elibalulekileyo kwi-Antengene nakwizigulane ze-MM e-Australia. Sivuyiswa kakhulu ukuba siqalise i-XPOVIO® kwaye sizise oogqirha base-Australia kunye nezigulane ukongeza inoveli kwiirejimeni zabo ezikhoyo zonyango lwe-R / R MM. Njengemveliso yethu yokuqala yokubhaliswa e-Australia, iphinda ibonise ukuguquka kwe-Antengene e-Australia ibe yintlangano ye-biopharmaceutical ngokuzibophezela ekuphuhliseni okuqhubekayo kunye nokuthengiswa kwamayeza okuguqula umhlaza kunye nezinye izifo ezisongela ubomi e-Australia, "kusho uThomas Karalis. CVP Asia Pacific of Antengene.
“Uthotho lwezamkelo olunikwe iXPOVIO® eTshayina, eMzantsi Korea, eSingapore kwaye ngoku eOstreliya kwezi nyanga zintandathu zidlulileyo lubonise ukuba leli chiza linamandla amakhulu onyango. E-Australia, kukho malunga nama-2,400 amatyala afunyanwe e-MM minyaka yonke, ngaloo ndlela ebonisa imfuno engxamisekileyo yekliniki kunyango lwe-MM, "utshilo uJay Mei, uMseki we-Antengene, uSihlalo kunye ne-CEO. “Olu lwamkelo lwe-TGA luziqhelanisa nokutshintsha izigulana zaseOstreliya ekudala zikhathazwa yiMM. Sizimisele ukuzisa iziyobisi ezintsha kunye nonyango kwizigulane ezinomhlaza okanye ezinye izifo ezibeka ubomi emngciphekweni kummandla we-Asia Pacific nakwihlabathi jikelele. Ngoku, iqela lethu lezorhwebo lizilungiselele kakuhle ukwandisa ukufikelela kwezigulana kolu nyango luvelayo, sisakhela phezu kwamava ethu orhwebo ngokuqaliswa kweXPOVIO® eTshayina, eSingapore naseMzantsi Korea.
INTO ONOKUYITHATHA KWELI NQAKU:
- (1) In combination with bortezomib and dexamethasone (XBd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy and (2) in combination with dexamethasone (Xd) for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory medicinal product (IMiD), and an anti-CD38 monoclonal antibody (mAb).
- Professor Hang Quach further commented “I believe that the first three lines of therapy for MM are the most important in dictating a patient’s overall survival because the majority of patients with MM in the real-world setting will not live to see fourth line of treatment or beyond.
- As our first product to be registered in Australia, it also marks the evolution of Antengene in Australia into a biopharmaceutical organization with a commitment to continued development and commercialization of transformational medicines for cancer and other life-threatening diseases in Australia,”.
