Ku ya 8 Mutarama 2025, Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeje PADCEVTM (enfortumab vedotin) hamwe na KEYTRUDA (pembrolizumab) ku barwayi bakuru bafite kanseri y’inkondo y’umura iteye imbere mu gace runaka cyangwa iterwa n’imisemburo ya kanseri y’umura (la/mUC).

Kwemeza kwa NMPA kwa vedotin ya enfortumab hamwe na pembrolizumab bishyigikiwe n'ibyavuye mu igerageza rya EV-302 rya Phase 3 (rizwi kandi nka KEYNOTE-A39). Igerageza ryagaragaje ko uburyo bwo kuvura bwazamuye uburyo bwo kubaho hagati y’imiti yose (OS) n’uburyo bwo kubaho hagati y’imiti idafite progression (PFS) hamwe n’ibisubizo bifite ireme mu mibare ku barwayi bafashwe na la/mUC mbere y’uko bavurwa ugereranije n’uburyo bwo kuvura bwa platine. Uburyo bwo kuvura bwamaze amezi 31.5 (95% CI: 25.4-NR) bwagezweho hamwe n’uburyo bwo kuvura bwamaze amezi 16.1 (95% CI: 13.9-18.3) hamwe n’uburyo bwo kuvura bwamaze amezi platine, bigaragaza ko ibyago byo gupfa bigabanukaho 53% (Igipimo cy’ibyago [HR] = 0.47; 95% Interval Confidence [CI]: 0.38-0.58; P <0.00001). Igipimo cya PFS cy’amezi 12.5 (95% CI: 10.4-16.6) cyagaragaye hamwe n’ubuvuzi buvanze ugereranije n’amezi 6.3 (95% CI: 6.2-6.5) hakoreshejwe imiti ya platine irimo platine, bigaragaza ko ibyago byo kwiyongera kwa kanseri cyangwa urupfu bigabanukaho 55% (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Ibisubizo by’umutekano byari bihuye n’ibyavuzwe mbere kuri ubu buryo bwo kuvura, kandi nta kibazo gishya cy’umutekano cyagaragaye.
Ku bijyanye na kanseri y'inkari n'umuyoboro w'inkari
Kanseri y'uruhago, cyangwa kanseri y'uruhago, itangirira mu tunyangingo tw'umuyoboro w'inkari, turi ku muyoboro w'inkari, uruhago rw'inkari, uruhago rw'impyiko, n'izindi ngingo zimwe na zimwe.4 Kanseri y'uruhago ifata 90% bya kanseri zose z'uruhago kandi ishobora no kuboneka mu ruhago rw'impyiko, uruhago rw'inkari, n'uruhago rw'inkari. Iyo kanseri y'uruhago yakwirakwiriye mu ngingo cyangwa imitsi ikikije, yitwa indwara yateye imbere mu gace runaka. Iyo kanseri yakwirakwiriye mu bindi bice by'umubiri, yitwa indwara yateye imbere.8 Hafi 12% by'abarwayi ni kanseri yateye imbere mu gace runaka cyangwa kanseri yateye imbere mu gace runaka iyo ivuwe.
Mu Bushinwa, igipimo cy’ubwiyongere bw’abandura kanseri y’uruhago mu 2022 cyari ku mwanya wa 11 muri kanseri zose, aho abantu barenga 92.000 banduye muri uwo mwaka. Imyaka itanu y’ubwiyongere bw’abandura kanseri y’uruhago mu Bushinwa ibarirwa muri 2.5 ku 100.000, cyangwa abarwayi 276.102. Kuvura no gukurikirana buri gihe bituma kanseri y’uruhago iba imwe mu ndwara zihenze cyane mu buzima bw’umurwayi, kandi ikaba kanseri ihenze cyane ugereranije n’izindi kanseri.
Ibyerekeye PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) ni umuti wa mbere mu bwoko bwa antibody-drug conjugate (ADC) urwanya Nectin-4, poroteyine iherereye ku buso bw'uturemangingo kandi igaragara cyane muri kanseri y'uruhago. Amakuru atari ay'ubuvuzi agaragaza ko imikorere ya vedotin yo kurwanya kanseri ya enfortumab iterwa no kwihuza n'uturemangingo twitwa Nectin-4, hanyuma hagakurikiraho gushyira no kurekura monomethyl auristatin E (MMAE) irwanya kanseri mu turemangingo, bigatuma utwo turemangingo tudakomeza kubyara (guhagarara k'uturemangingo) no gupfa kw'uturemangingo (apoptosis).
PADCEV igaragazwa mu Bushinwa nk'uburyo bwo kuvura abarwayi bakuru bafite kanseri y'uryotiya iteye imbere cyangwa itera kanseri y'uryotiya nyuma yo kuvurwa mbere hakoreshejwe imiti ya platine irimo platine na porogaramu ya receptor y'urupfu-1 (PD-1) cyangwa porogaramu ya PD-L1 igabanya ubukana bw'indwara, ndetse ikanakoreshwa hamwe na KEYTRUDA (pembrolizumab) ku barwayi bakuru bafite kanseri y'uryotiya iteye imbere cyangwa itera kanseri y'uryotiya.
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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Amareferensi
2.Urupapuro rwitangiriro rwa Astellas | Yamazaki Inc.
3.https://www.nejm.org/doi/full/10.1056/NEJMoa2035807
Igihe cyo kohereza: Gashyantare-21-2025
