Thaum Lub Ib Hlis 8, 2025, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo PADCEVTM (enfortumab vedotin) ua ke nrog KEYTRUDA (pembrolizumab) rau cov neeg laus uas muaj mob qog noj ntshav hauv lub cev (la/mUC).
NMPA txoj kev pom zoo ntawm enfortumab vedotin ua ke nrog pembrolizumab yog txhawb nqa los ntawm cov txiaj ntsig los ntawm Theem 3 EV-302 kev sim tshuaj (tseem hu ua KEYNOTE-A39). Kev sim tshuaj tau qhia tias kev sib xyaw ua ke ntawm kev kho mob tau txhim kho qhov nruab nrab ntawm kev ciaj sia tag nrho (OS) thiab qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (PFS) nrog rau cov txiaj ntsig tseem ceeb thiab muaj txiaj ntsig zoo rau cov neeg mob uas tau kho la/mUC yav dhau los piv rau kev kho mob chemotherapy uas muaj platinum. Qhov nruab nrab ntawm OS ntawm 31.5 lub hlis (95% CI: 25.4-NR) tau ua tiav nrog kev sib xyaw ua ke ntawm kev kho mob piv rau 16.1 lub hlis (95% CI: 13.9-18.3) nrog kev kho mob chemotherapy uas muaj platinum, uas sawv cev rau kev txo qis 53% ntawm kev pheej hmoo ntawm kev tuag (Hazard Ratio [HR] = 0.47; 95% Confidence Interval [CI]: 0.38-0.58; P <0.00001). Qhov nruab nrab PFS ntawm 12.5 lub hlis (95% CI: 10.4-16.6) tau tshaj tawm nrog kev kho mob ua ke piv rau 6.3 lub hlis (95% CI: 6.2-6.5) nrog kev kho mob chemotherapy uas muaj platinum, uas sawv cev rau kev txo qis 55% ntawm kev pheej hmoo ntawm kev mob qog noj ntshav nce lossis tuag (HR = 0.45; 95% CI: (0.38-0.54); P < 0.00001). Cov txiaj ntsig kev nyab xeeb tau sib xws nrog cov uas tau tshaj tawm yav dhau los nrog kev kho mob ua ke no, thiab tsis muaj teeb meem kev nyab xeeb tshiab tau pom.
Txog Kab Mob Cancer ntawm Lub Zis thiab Urothelial
Mob qog nqaij hlav urothelial, lossis mob qog nqaij hlav ntawm lub zais zis, pib hauv cov hlwb urothelial, uas nyob rau ntawm txoj hlab zis, lub zais zis, txoj hlab zis, lub plab mog raum, thiab qee lwm yam kabmob.4 Mob qog nqaij hlav urothelial suav txog 90% ntawm tag nrho cov mob qog nqaij hlav ntawm lub zais zis thiab kuj tuaj yeem pom hauv lub plab mog raum, txoj hlab zis, thiab txoj hlab zis. Yog tias mob qog nqaij hlav ntawm lub zais zis tau kis mus rau cov kabmob lossis cov leeg nqaij ib puag ncig, nws hu ua mob qog nqaij hlav hauv zos. Yog tias mob qog nqaij hlav tau kis mus rau lwm qhov ntawm lub cev, nws hu ua mob qog nqaij hlav kis mus rau lwm qhov.8 Kwv yees li 12% ntawm cov neeg mob yog mob qog nqaij hlav urothelial uas kis mus rau lwm qhov hauv lub cev thaum kuaj pom.
Nyob rau hauv Suav teb, tus nqi ntawm kev mob qog noj ntshav hauv xyoo 2022 yog qib 11th ntawm txhua yam mob qog noj ntshav, nrog ntau dua 92,000 tus neeg mob tshiab kuaj pom xyoo ntawd. Tsib xyoos ntawm kev mob qog noj ntshav hauv Suav teb kwv yees li 2.5 / 100,000 tus neeg mob, lossis 276,102 tus neeg mob. Kev kho mob tas mus li thiab kev saib xyuas ua rau mob qog noj ntshav hauv lub zais zis yog ib hom mob qog noj ntshav kim tshaj plaws hauv lub neej ntawm tus neeg mob, thiab yog mob qog noj ntshav kim tshaj plaws thaum piv rau lwm yam mob qog noj ntshav.
Txog PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) yog thawj zaug hauv chav kawm antibody-drug conjugate (ADC) uas yog taw qhia tawm tsam Nectin-4, ib qho protein nyob rau ntawm qhov chaw ntawm cov cell thiab qhia tawm heev hauv mob qog noj ntshav hauv lub zais zis. Cov ntaub ntawv tsis yog kev kho mob qhia tias kev ua haujlwm tiv thaiv mob qog noj ntshav ntawm enfortumab vedotin yog vim nws khi rau Nectin-4-expressing cell, ua raws li kev nkag mus rau hauv thiab tso tawm ntawm tus neeg sawv cev tiv thaiv mob qog noj ntshav monomethyl auristatin E (MMAE) rau hauv lub cell, uas ua rau lub cell tsis rov tsim dua (cell cycle arrest) thiab hauv programmed cell death (apoptosis).
PADCEV tau qhia nyob rau hauv Suav teb ua monotherapy rau kev kho mob rau cov neeg laus uas muaj mob qog noj ntshav urothelial uas tau nce qib hauv zos lossis metastatic tom qab kev kho mob ua ntej nrog platinum-containing chemotherapy thiab programmed death receptor-1 (PD-1) lossis programmed death-ligand 1 (PD-L1) inhibitors, thiab ua ke nrog KEYTRUDA (pembrolizumab) rau cov neeg laus uas muaj mob qog noj ntshav urothelial uas tau nce qib hauv zos lossis metastatic.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
2.Astellas Tsev nplooj ntawv | Astellas Pharma Inc.
3.https://www.nejm.org/doi/full/10.1056/NEJMoa2035807
Lub sijhawm tshaj tawm: Lub Ob Hlis-21-2025