NMPA yemeje Zanidatamab ku ndwara ya HER2 Advanced Biliary Tract Cancer​

Ku ya 29 Gicurasi, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) cyemeje icuruzwa rya Zanidatamab, ryatanzwe na BeiGene, mu kuvura abarwayi barwaye kanseri y’inkari idakira mu gace runaka cyangwa kanseri y’inkari itera ubwandu (BTC) babanje guhabwa ubuvuzi bw’umubiri kandi bagaragaza HER2 nyinshi (IHC 3+).

Zanidatamab ni antibody y’ubushakashatsi ya HER2-target bispecific antibody ishobora gufata icyarimwe epitopes ebyiri zitahurirana za HER2 receptor, izwi nka biparatopic binding. Iyi miterere idasanzwe hamwe no kwiyongera kw’imifatanire bitanga uburyo bwinshi bwo gukora, harimo gufunga ibimenyetso bibiri bya HER2, gukuraho poroteyine ya HER2 ku buso bw’uturemangingo, no guhumanya umubiri binyuze mu buvuzi bigatuma abarwayi bagira uruhare mu kurwanya kanseri.

Receptor tyrosine-protein kinase, izwi cyane nka Human Epidermal Growth Factor Receptor 2 (HER2) cyangwa CD340, iherereye ku buso bw'uturemangingo. Iyi poroteyine ni imwe mu zigize umuryango wa Epidermal Growth Factor Receptor (EGFR) kandi ishingiye kuri gene ya Erythroblastic oncogene B (ERBB2). ERBB2 gene ni ingenzi mu mikorere isanzwe nko kwigabanyamo ibice, gutandukanya no kubaho. Binyuze mu nzira zitandukanye zo gutanga ibimenyetso, HER2 receptors zitera kwiyongera kw'uturemangingo no kubuza apoptosis (urupfu rw'uturemangingo rwateguwe). Ni ngombwa kugenzura izi receptor kugira ngo hirindwe gukura gukabije kw'uturemangingo. Kanseri zigaragaza cyane cyangwa zikongera HER2 gene zitwa HER2-positive malignancies. Iyi gene ikora nk'ikimenyetso cy'ingenzi kandi ni intego y'ingenzi yo kuvura imiti.

Ariko, iyo HER2 yongerewe cyangwa ikagaragara cyane, kwiyongera kw'uturemangingo no kwigabanyamo ibice bidagenzuwe byihutisha kwiyongera kwa kanseri. Uku kwiyongera cyangwa kwiyongera cyane bikunze kuboneka mu bwoko butandukanye bwa kanseri kandi bishobora kugira akamaro gakomeye mu kuvura kanseri idakunze kwitezweho kwakira neza imiti irwanya HER2.

Kurwara kanseri ya HER2 biboneka mu bwoko butandukanye bwa kanseri nka kanseri yo mu gifu, yo mu nzira y'inkari, yo mu ibere, yo mu gituza, yo mu dusabo tw'intanga, no mu mura. Uburyo kanseri ya HER2 igaragara, ibisobanuro byayo, n'uburyo ivurwa buri kimwe cya kanseri ya HER2 bigaragara mu mbonerahamwe. Vuba aha, havumbuwe isano iri hagati ya kanseri ya pancreas na biliary tract (BTC). Abarwayi ba kanseri ya HER2 bakunze kugira ikibazo gito ugereranije n'abafite kanseri ya HER2, kuko iyi kanseri irushaho kuba mbi. Ariko, ingamba nshya zo kuvura zagaragaje umusaruro mwiza.

Uku kwemezwa gushingiye ku byavuye mu bushakashatsi bw’ingenzi bwa HERIZON-BTC-01 (NCT04466891). Ubu bushakashatsi bwari inyigo mpuzamahanga, y’ibigo byinshi, ifunguye, ifite ukuboko kumwe, yakozwe mu cyiciro cya 2b, yagenewe gusuzuma imikorere n’umutekano wa zanidatamab ku barwayi bavuwe mbere, badafite HER2-amplified advanced cyangwa metastatic BTC.

Ubushakashatsi bwagaragaje abarwayi 87 ba BTC, barimo 62 bafite HER2 nyinshi. Ibisubizo byagaragaje ko Zanidatamab monotherapy yagaragaje akamaro kanini mu buvuzi ku barwayi bavuwe mbere bafite BTC iri hejuru ya HER2. Igipimo cy’igisubizo cy’ibanze (ORR) cyasuzumwe ku giti cyabo cyari 51.6%, aho igipimo cy’igihe cy’igisubizo (mDoR) cyari amezi 14.9, igipimo cy’igihe cy’impinduka (mPFS) cyari amezi 7.2, n’igipimo cy’igihe cy’impinduka muri rusange (mOS) cyari amezi 18.1.

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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