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Sabuwar Aikace-aikacen Magunguna don Maganin Ciwon Kankara mara Karami

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CStone Pharmaceuticals, wani kamfani na biopharmaceutical da ke mayar da hankali kan bincike, haɓakawa, da tallace-tallace na ingantattun hanyoyin kwantar da hankali na rigakafi da magunguna, sun sanar a yau cewa sabon aikace-aikacen magani (NDA) don pralsetinib don maganin sake tsarawa yayin kamuwa da cuta (RET) fusion-tabbatacce a gida. ci-gaba ko metastatic non-kananan cell huhu ciwon daji (NSCLC) an karɓa a Hong Kong, China.

Pralsetinib shine mai hanawa mai ƙarfi kuma zaɓi na RET wanda abokin aikin CStone Magungunan Blueprint ya gano. CSstone yana da haɗin gwiwa na musamman da yarjejeniyar lasisi tare da Magungunan Blueprint don haɓakawa da kasuwancin pralsetinib a cikin Babban China, wanda ya ƙunshi Mainland China, Hong Kong, Macau da Taiwan.

Dokta Jason Yang, babban jami'in kula da lafiya na CSstone, ya ce, "Muna matukar farin ciki cewa NDA na wani ingantaccen magani mai mahimmanci, pralsetinib, an yarda da shi don maganin ci gaba na RET fusion-positive NSCLC, bayan AYVAKIT® (avapritinib) an amince da shi. don maganin unresectable ko metastatic PDGFRA D842V mutant gastrointestinal stromal ciwace-ciwacen daji a Hong Kong, China a watan Disamba 2021. A cikin duniya lokaci 1/2 ARROW binciken, pralsetinib ya nuna m asibiti fa'idodin da kuma gaba ɗaya da jure aminci profile a cikin marasa lafiya tare da RET fusion -tabbatacce na ci gaba na gida ko metastatic NSCLC. Muna fatan yuwuwar amincewar pralsetinib a Hong Kong, China don taimakawa mafi yawan marasa lafiya da sauri.

Karɓar NDA na pralsetinib a Hong Kong, China ya dogara ne akan sakamakon binciken 1/2 ARROW na duniya. An tsara wannan gwaji don kimanta aminci, haƙuri, da ingancin pralsetinib a cikin marasa lafiya tare da RET-fusion tabbatacce NSCLC, RET-mutant medullary thyroid cancer (MTC), da sauran ciwace-ciwacen ciwace-ciwace tare da fusions na RET.

Sakamako daga gwajin ARROW a cikin marasa lafiya na duniya tare da ci gaba na RET fusion-tabbatacce NSCLC an gabatar da su a taron 2021 American Society of Clinical Oncology (ASCO) Taron Shekara-shekara a watan Yuni 2021. Ya zuwa ranar da za a yanke ranar Nuwamba 6, 2020, pralsetinib ya nuna asibiti mai ɗorewa. fa'idodi a cikin marasa lafiya tare da RET fusion-tabbatacce NSCLC waɗanda ke da cutar da za a iya aunawa a asali kuma sun karɓi kashi na farawa na MG 400 sau ɗaya kowace rana.

• A cikin marasa lafiya na 68 marasa lafiya, yawan amsawa gaba ɗaya (ORR) shine 79 bisa dari (95% CI: 68%, 88%). Cikakken amsa (CR) shine kashi 6 cikin dari, kashi 10 cikin dari na marasa lafiya suna da cikakkiyar koma baya na ciwace-ciwacen ciwace-ciwacen daji, kuma kashi 74 cikin dari na marasa lafiya suna da martani mai ƙarfi (PR). Ba a kai matsakaicin lokacin amsawa (DOR) ba (95% CI: watanni 9.0, ba a kai ba).

• A cikin marasa lafiya na 126 waɗanda a baya sun karɓi maganin cutar sankara na platinum, ORR shine 62 bisa dari (95% CI: 53%, 70%). Adadin CR shine kashi 4 cikin dari, kashi 12 cikin dari na marasa lafiya suna da cikakkiyar koma bayan ciwace-ciwacen ciwace-ciwacen daji, kuma kashi 58 na marasa lafiya suna da PR. Matsakaicin DOR shine watanni 22.3 (95% CI: watanni 15.1, ba a kai ba).

• Ya zuwa ranar yanke bayanan, an yi rajistar marasa lafiya 471 a cikin nau'ikan ciwon sukari tare da adadin pralsetinib wanda ya fara a 400 MG sau ɗaya kowace rana. Abubuwan da suka fi dacewa da jiyya (AEs) waɗanda masu bincike suka ruwaito sune neutropenia, ƙara yawan aspartate aminotransferase, anemia, rage yawan adadin jinin jini, ƙarar alanine aminotransferase, hauhawar jini, maƙarƙashiya da asthenia.

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edita

Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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