Ku ya 15 Mata 2025, InnoCare Pharma yatangaje ko Ikigo gishinzwe gusuzuma imiti (CDE) cy’Ikigo cy’Igihugu cy’Ubushinwa gishinzwe imiti y’ubuvuzi (NMPA) cyemeye Porogaramu Nshya y’Imiti (NDA) yo mu bwoko bushya bw’umuti w’ingufu zurletrectinib (ICP-723) wo kuvura abarwayi bakuru n’ingimbi (imyaka 12 kugeza kuri 18) bafite ibibyimba bikomeye birimo ihuriro ry’uturemangingo twa NTRK.

Utunyangingo twa NTRK duhurira mu bwoko butandukanye bw'ibibyimba by'abantu bakuru n'iby'abana. Muri bimwe mu bibyimba bidakunze kugaragara, nka kanseri y'amacandwe, kanseri y'ibere ikora ku munwa, na fibrosarcoma y'abana bato, umubare w'ibibyimba bya NTRK urenga 90% [1]. Bivugwa ko hari abantu bashya bagera ku 6.500 banduye ibibyimba bikomeye bya NTRK bivurwa buri mwaka, mu Bushinwa. Hari ibyifuzo by'ubuvuzi bidahagije muri uru rwego bitewe no kutagira uburyo bwiza bwo kuvura.
Zurletrectinib ni umuti mushya uherutse gutegurwa wo kurwanya TRK yo mu gisekuru gishya wagaragaje imikorere irwanya TRK WT na mutant kinases.
Ikinyamakuru British Journal of Cancer, kimwe mu bigize ikinyamakuru gikomeye cya siyansi Nature, cyasohoye inyandiko yise “Zurletrectinib ni umuti ubuza TRK wo mu gisekuru gikurikira ufite imikorere ikomeye mu kurwanya ibibyimba bya NTRK fusion hamwe no kudahuza n’ibintu byo mu gisekuru cya mbere”. Iki kinyamakuru cyanzuye ko zurletrectinib ari umuti ubuza TRK wo mu gisekuru gikurikira, ufite ubushobozi bwinshi bwo kwinjira mu bwonko mu mubiri no gukora cyane mu gisekuru gikurikira kurusha ibindi bintu byo mu gisekuru gikurikira.
Iyi nyandiko yagaragaje ko zurletrectinib yagaragaje imbaraga zikomeye mu kurwanya TRKA, TRKB, na TRKC WT kinases, ndetse no mutations za TRKA G595R na TRKA G667C. Zurletrectinib yari ifite imbaraga kurusha izindi TRK inhibitors zemewe na FDA cyangwa zapimwe na muganga (larotrectinib) n'izakurikiyeho (selitrectinib na repotrectinib) mu kurwanya mutations nyinshi za TRK inhibitors. Mu buryo nk'ubwo, zurletrectinib (1 mg/kg BID) yabujije gukura kwa kanseri mu buryo bwa xenograft bukomoka ku turemangingo twa NTRK fusion-positive ku gipimo kiri hasi inshuro 30 ugereranije na selitrectinib.
Iyi nyandiko yakomeje igaragaza ko, mu bushakashatsi bwakozwe ku mbeba za SD (CNS), zurletrectinib yagaragaje ubushobozi bwo kwinjira mu ruzitiro rw'amaraso n'ubwonko, ikagera mu bwonko neza kurusha selitrectinib na repotrectinib. Kwinjira k'ubwonko kwa Zurletrectinib byanahinduwe mu mikorere myiza yo kurwanya kanseri. Mu buryo bwa genegrafi ya glioma xenograft y’imbeba ifite TRKA G598R/G670A resistance mutation, zurletrectinib (15 mg/kg) yongereye cyane ubuzima bw’imbeba zifite gliomas za TRK zitanduye (median life = 41.5, 66.5, na 104 kuri selitrectinib, repotrectinib, na zurletrectinib uko bikurikirana; P < 0.05), igaragaza imikorere myiza ugereranije na repotrectinib (15 mg/kg) na selitrectinib (30 mg/kg) (P= 0.0384 na 0.0022, uko bikurikirana), hamwe n’umutekano mwiza.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Igihe cyo kohereza: 17 Mata 2025
