Zurletrectinib yahawe isuzuma ry'ibanze riturutse muri NMPA yo mu Bushinwa

Ku ya 25 Mata 2025, InnoCare Pharma yatangaje ko icyorezo gishya cya pan-TRK inhibitor zurletrectinib (ICP-723) cyemejwe n'Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi cy'Ubushinwa (NMPA), cyemeye Porogaramu Nshya y'Imiti ya zurletrectinib mu kuvura abarwayi bafite ibibyimba bikomeye bifite imiterere ya NTRK iherutse. Isuzuma ry'ibanze ni imwe muri politiki z'ingenzi zashyizweho na CDE kugira ngo hihutishwe kwemerwa kw'imiti.

Mu igerageza ryo kwiyandikisha ku barwayi bafite ibibyimba bikomeye bya NTRK fusion-positive, zurletrectinib yagaragaje imikorere myiza cyane hamwe n’umutekano mwiza.

Dr. Jasmine Cui, umwe mu bashinze InnoCare, akaba n'umuyobozi mukuru, yagize ati: “Twishimiye ko zurletrectinib yahawe isuzuma ry’ibanze. Zurletrectinib yagaragaje imikorere myiza n’umutekano mwiza. Twiteze ko izatanga uburyo bwiza bwo kuvura abarwayi bujuje ibisabwa bafite ibibyimba bikomeye hakiri kare.”

Zurletrectinib ni umuti ugabanya ubukana bwa pan-TRK wakozwe na InnoCare. Ikinyamakuru cy’Ubwongereza cya Cancer, kimwe mu bigize ikinyamakuru gikomeye cya siyansi Nature, cyasohoye inyandiko yise “Zurletrectinib ni umuti ugabanya ubukana bwa TRK wo mu gisekuru gikurikira ufite imbaraga zikomeye mu kurwanya ibibyimba bya NTRK bifite ubudahangarwa ku binyabuzima byo mu gisekuru cya mbere”.

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.

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%. Bivugwa ko hari abantu bashya bagera ku 6.500 barwaye ibibyimba bikomeye bya NTRK bivurwa mu Bushinwa buri mwaka. Hari ibikenewe cyane mu buvuzi muri uru rwego bitewe no kutagira uburyo bwiza bwo kuvura.

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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