Isicelo Esisha Somuthi Wokwelapha Umdlavuza Ongewona Omncane Wengqamuzana Wamaphaphu

A BAMBA MahhalaRelease 5 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

I-CSstone Pharmaceuticals, inkampani ye-biopharmaceutical egxile ocwaningweni, ekuthuthukisweni, nasekudayiseni izindlela zokwelapha ezintsha ze-immuno-oncology kanye nemithi enembile, imemezele namuhla ukuthi isicelo esisha sesidakamizwa (i-NDA) se-pralsetinib sokwelashwa okuhlelwe kabusha ngesikhathi sokudluliselwa (RET) fusion-positive endaweni. Umdlavuza wamaphaphu othuthukile noma we-metastatic non-small cell lung (NSCLC) wamukelwe eHong Kong, eChina.

I-Pralsetinib iyi-RET inhibitor enamandla futhi ekhethiwe etholwe nguzakwethu we-CStone i-Blueprint Medicines. I-CStone inesivumelwano esikhethekile sokusebenzisana nelayisensi ne-Blueprint Medicines yokuthuthukiswa nokudayiswa kwe-pralsetinib e-Greater China, ehlanganisa i-Mainland China, i-Hong Kong, i-Macau ne-Taiwan.

UDkt. Jason Yang, Isikhulu Esiphezulu Sezokwelapha se-CSstone, uthe, “Sijabula kakhulu ngokuthi i-NDA yomunye umuthi onembile, i-pralsetinib, yamukelwe ukuze welaphe i-RET fusion-positive NSCLC ethuthukisiwe, ngemva kokugunyazwa kwe-AYVAKIT® (avapritinib) yokwelashwa kwezimila ezingasahleki noma ezine-metastatic ze-PDGFRA D842V eziguqukayo zesisu e-Hong Kong, e-China ngoDisemba 2021. Ocwaningweni lomhlaba jikelele lwesigaba 1/2 se-ARROW, i-pralsetinib ibonise izinzuzo zomtholampilo ezihlala isikhathi eside kanye nephrofayili yokuphepha ebekezelelwe kahle ezigulini ezine-RET fusion. -i-NSCLC ethuthukisiwe yasendaweni noma ene-metastatic. Sibheke ngabomvu ukugunyazwa okungenzeka kwe-pralsetinib eHong Kong, eChina ukusiza iziguli eziningi ngokushesha okukhulu. ”

Ukwamukelwa kwe-NDA kwe-pralsetinib e-Hong Kong, e-China kusekelwe emiphumeleni evela ocwaningweni lomhlaba wonke lwesigaba 1/2 se-ARROW. Lolu cwaningo luklanyelwe ukuhlola ukuphepha, ukubekezelelana, kanye nempumelelo ye-pralsetinib ezigulini ezine-RET-fusion positive NSCLC, i-RET-mutant medullary thyroid cancer (MTC), nezinye izimila eziqinile ezithuthukisiwe ezine-RET fusions.

Imiphumela evela ocwaningweni lwe-ARROW ezigulini zomhlaba ezine-RET fusion-positive NSCLC ethuthukisiwe yethulwa eMhlanganweni Waminyaka yonke we-2021 American Society of Clinical Oncology (ASCO) ngoJuni 2021. Kusukela ngedethi yokuvala yangomhla zi-6 Novemba 2020, i-pralsetinib yabonisa isikhathi eside somtholampilo. izinzuzo ezigulini ezine-RET fusion-positive NSCLC ezazinesifo esilinganisekayo ekuqaleni futhi zathola umthamo wokuqala wama-400 mg kanye ngosuku.

• Ezigulini ezingama-68 ezingenazo ukwelashwa, izinga lokuphendula lilonke (ORR) lalingu-79% (95% CI: 68%, 88%). Izinga lokuphendula eliphelele (CR) lalingamaphesenti angu-6, amaphesenti angu-10 eziguli ayenokuhlehla okuphelele kwezimila ezihlosiwe, futhi amaphesenti angu-74 eziguli abe nokusabela okuyingxenye (PR). Isikhathi esimaphakathi sokuphendula (DOR) asifinyelelwanga (95% CI: 9.0 izinyanga, asifinyelelwanga).

• Ezigulini eziyi-126 ezake zathola ukwelashwa ngamakhemikhali okusekelwe ku-platinum, i-ORR yayingamaphesenti angu-62 (95% CI: 53%, 70%). Izinga le-CR lalingamaphesenti angu-4, amaphesenti angu-12 eziguli ayenokuhlehla okuphelele kwezimila ezihlosiwe, kanti amaphesenti angu-58 eziguli ayene-PR. I-DOR emaphakathi kwakuyizinyanga ezingu-22.3 (95% CI: izinyanga ezingu-15.1, azifinyelelwanga).

• Kusukela ngosuku lokunqanyulwa kwedatha, isamba seziguli ezingama-471 zabhaliswa kuzo zonke izinhlobo zesimila ngomthamo we-pralsetinib oqala ku-400 mg kanye ngosuku. Izehlakalo ezimbi kakhulu ezihlobene nokwelashwa (AEs) ezibikwe ngabaphenyi kwakuyi-neutropenia, ukwanda kwe-aspartate aminotransferase, i-anemia, ukwehla kwenani lamangqamuzana egazi amhlophe, ukwanda kwe-alanine aminotransferase, umfutho wegazi ophakeme, ukuqunjelwa kanye ne-asthenia.

Mayelana umbhali

Isithombe sikaLinda Hohnholz

Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

Bhalisa
Yazisa ngakho
isivakashi
0 Amazwana
Okungaphakathi Okuphakelayo
Buka wonke amazwana
0
Ungathanda imibono yakho, ngicela uphawule.x
Yabelana ku...