Watsopano mankhwala ntchito mankhwala a chithokomiro khansa

CSstone Pharmaceuticals lero yalengeza kuti National Medical Products Administration (NMPA) yaku China yavomereza supplemental new drug application (sNDA) ya selective RET inhibitor GAVRETO® (pralsetinib) yochiza RET-mutant medullary thyroid cancer (MTC) ndi RET fusion. -khansa yabwino ya chithokomiro (TC). Chivomerezocho chinakulitsa zizindikiro zolembedwa za GAVRETO ku China kuti ziphatikize odwala achikulire ndi ana azaka 12 kapena kuposerapo omwe ali ndi matenda amtundu wa RET-mutant MTC omwe amafunikira chithandizo chamankhwala, komanso odwala akulu ndi ana azaka 12 ndi kupitilira apo omwe ali ndi matenda apamwamba kapena otupa. RET fusion-positive TC yemwe amafunikira chithandizo chamankhwala ndi radioactive ayodini-refractory (ngati mankhwala a radioactive ayodini ali oyenera).

Zadziwika ndi bwenzi la Cstone Blueprint Medicines, GAVRETO ndi choletsa champhamvu komanso chosankha cha RET. Cstone ili ndi mgwirizano wapadera ndi mgwirizano wa chilolezo ndi Blueprint Medicines pa chitukuko ndi malonda a GAVRETO ku Greater China, yomwe imaphatikizapo Mainland China, Hong Kong, Macau ndi Taiwan.

Dr. Frank Jiang, Wapampando ndi Mtsogoleri wamkulu wa Cstone, adati, "Ndife okondwa kwambiri ndi kuvomereza kwa sNDA kwa GAVRETO, yomwe idzapereka njira yatsopano yothandizira odwala achi China omwe ali ndi khansa ya chithokomiro ya RET-mutant medullary komanso khansa ya chithokomiro ya RET fusion-positive . Tikufunanso kupereka kuthokoza kwathu kwapadera kwa NMPA kaamba ka kuunikanso koyambirira. CSstone nthawi zonse amadzipereka kupanga njira zochiritsira zatsopano kuti athe kuthana ndi zosowa zachipatala za odwala khansa. Tipitiliza kukulitsa phindu lachipatala komanso kuthekera kwa mapaipi athu, ndikuyesetsa kupatsa odwala padziko lonse lapansi mankhwala apamwamba komanso anzeru. "

Pulofesa Ming Gao, Wofufuza Wamkulu wa kafukufuku wa ARROW komanso Purezidenti wa Tianjin Union Medical Center, anati, "Chiwopsezo cha khansa ya chithokomiro chawonjezeka m'zaka zaposachedwa. Pali njira zochepetsera zachipatala zochizira MTC, ndipo pakufunika mwachangu chithandizo cholondola, makamaka kwa odwala omwe ali ndi RET-mutant MTC. GAVRETO adawonetsa ntchito zolimbana ndi chotupa zamphamvu komanso zolimba mwa odwala aku China omwe ali ndi Advanced or metastatic RET-mutant MTC, ndipo chitetezo chonse chimagwirizana ndi zotsatira zomwe zawonedwa mu kafukufuku wapadziko lonse wa ARROW. Ndi kuwonjezereka kwa zizindikiro zolembedwa za GAVRETO, tikuyembekeza kuthana ndi zosowa zachipatala za odwala khansa ya chithokomiro.

Dr. Jason Yang, Chief Medical Officer wa Cstone, anati, "Kuvomereza kwa NMPA kwa sNDA ndi chinthu china chofunika kwambiri kwa ife pambuyo povomerezedwa ndi GAVRETO kuti athe kuchiza odwala omwe ali ndi khansa ya m'mapapo yapamwamba kapena ya metastatic RET fusion-positive non-small cell m'mapapo. . Tikufuna kuthokoza odwala onse ndi ofufuza omwe adathandizira nawo pa kafukufuku wachipatala wa GAVRETO pazidziwitso zomwe zakulitsidwa. Tipitiliza kupititsa patsogolo kafukufuku wazachipatala wa GAVRETO pochiza mitundu ingapo ya khansa kuti titha kubweretsa chithandizo chatsopanochi chothandizira odwala ambiri. ”

Chivomerezo cha sNDA chimachokera ku zotsatira za kuyesa kwapadziko lonse kwa gawo la 1/2 la ARROW, lopangidwa kuti liwunikire chitetezo, kulolera ndi mphamvu ya GAVRETO kwa odwala omwe ali ndi RET fusion-positive NSCLC, RET-mutant MTC, ndi zotupa zina zapamwamba zolimba zokhala ndi RET fusions. . Pofika tsiku lomaliza la Epulo 12, 2021, odwala 28 omwe anali ndi RET-mutant MTC yapamwamba adalembetsedwa mgulu lolembetsa la China MTC la kafukufuku wapadziko lonse wa ARROW, ndipo adalandira mlingo woyambira wa GAVRETO wa 400mg kamodzi patsiku. Zotsatira za phunziroli zinasonyeza kuti chiwerengero cha mayankho otsimikizika (ORR) cha 26 RET-mutant MTC odwala omwe ali ndi matenda oyezera pazigawo zoyambira anali 73.1%, kuphatikizapo 3 ndi yankho lathunthu (CR) ndi 16 ndi mayankho ang'onoang'ono (PR). Mlingo wowongolera matenda (DCR) unali 84.6%, ndipo mayankho adawonedwa mosasamala kanthu za RET mutation genotype. Pakati pa odwala 19 omwe ali ndi yankho lotsimikizika, nthawi yapakatikati yoyankha (DOR) sinafikire, ndipo mlingo wa DOR wa miyezi 9 unali 100%. Magulu a Calcitonin ndi carcinoembryonic antigen (CEA) adachepetsedwa kwambiri. GAVRETO nthawi zambiri imaloledwa bwino, popanda zizindikiro zatsopano zachitetezo zomwe zapezeka. Zotsatira za gulu lolembetsa ku China lolembetsa zidaperekedwa pagawo lakumapeto kwapamsonkhano wapachaka wa 90th Annual Meeting of the American Thyroid Association (ATA) 2021.