Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da VYLOYTM (zolbetuximab) don maganin ciwon daji na hanji ko na hanji

A ranar 31 ga Disamba, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da VYLOYTM (zolbetuximab), tare da maganin chemotherapy mai ɗauke da fluoropyrimidine da platinum, don maganin farko ga marasa lafiya da ke fama da ciwon daji na ciki wanda ba a iya cirewa ko kuma wanda ya kamu da cutar kansa ta ɗan adam mai suna 2 (HER2) wanda ciwonsa ke da claudin (CLDN) mai 18.2. Zolbetuximab shine maganin rigakafi na farko da NMPA ta amince da shi wanda ya kai hari ga ƙwayoyin ciwon ciki waɗanda ke nuna alamar CLDN18.2, wanda ke ba da hanyar magance cutar kansa mai matuƙar muhimmanci.

An samu goyon bayan amincewa da NMPA da zolbetuximab ta hanyar bayanai daga gwaje-gwajen asibiti na Phase 3 na GLOW da SPOTLIGHT na duniya, waɗanda suka haɗa da marasa lafiya 145 da 36 daga babban yankin China, bi da bi. Gwajin GLOW ya kimanta zolbetuximab da CAPOX (wani tsarin haɗin gwiwar chemotherapy wanda ya haɗa da capecitabine da oxaliplatin) idan aka kwatanta da placebo da CAPOX. Gwajin SPOTLIGHT ya kimanta zolbetuximab da mFOLFOX6 (wani tsarin haɗin gwiwa wanda ya haɗa da oxaliplatin, leucovorin da fluorouracil) idan aka kwatanta da placebo da mFOLFOX6.

Gwajin SPOTLIGHT ya kimanta zolbetuximab da mFOLFOX6 (wani tsari na haɗin gwiwa wanda ya haɗa da oxaliplatin, leucovorin da fluorouracil) idan aka kwatanta da placebo da mFOLFOX6. An nuna cewa maganin zolbetuximab yana ba da ci gaba mai mahimmanci a cikin rayuwa ba tare da ci gaba ba (PFS) da rayuwa gabaɗaya (OS) idan aka kwatanta da sauran magungunan kula da lafiyar marasa lafiya da suka cancanta waɗanda ke da cutar kansar ciki da GEJ. A cikin gwajin GLOW, an cimma matsakaicin PFS na watanni 8.21 tare da zolbetuximab da CAPOX a matsayin magani na farko idan aka kwatanta da watanni 6.80 tare da placebo da CAPOX. Matsakaicin OS shine watanni 14.39 idan aka kwatanta da watanni 12.16 a cikin ƙungiyoyin jiyya daban-daban. An ga irin wannan sakamakon tasiri a gwajin SPOTLIGHT, inda matsakaicin PFS ya kasance watanni 10.61 idan aka kwatanta da watanni 8.67, kuma matsakaicin tsarin aiki shine watanni 18.23 idan aka kwatanta da watanni 15.54, tare da zolbetuximab da mFOLFOX6, idan aka kwatanta da placebo da mFOLFOX6. A cikin gwaje-gwajen GLOW da SPOTLIGHT, yawan aukuwar mummunan sakamako na gaggawa (TEAEs) iri ɗaya ne a cikin ƙungiyoyin maganin zolbetuximab idan aka kwatanta da sarrafawa. Mafi yawan TEAEs na dukkan-mataki da aka ruwaito a cikin ƙungiyoyin maganin zolbetuximab sune tashin zuciya, amai da raguwar ci.

A cikin binciken da aka haɗa, matsakaicin rayuwa ba tare da ci gaba ba shine watanni 9.2 a cikin ƙungiyar zolbetuximab da watanni 8.2 a cikin ƙungiyar placebo (rabowar haɗari ga ci gaba ko mutuwa, 0.71; tazara ta amincewa ta 95% [CI], 0.61 zuwa 0.83). Jimillar marasa lafiya 377 daga cikin 537 (70.2%) a cikin ƙungiyar zolbetuximab da kuma marasa lafiya 424 daga cikin 535 (79.3%) a cikin ƙungiyar placebo sun mutu. Matsakaicin rayuwa gabaɗaya shine watanni 16.4 a cikin ƙungiyar zolbetuximab da watanni 13.7 a cikin ƙungiyar placebo (rabowar haɗari ga mutuwa, 0.77; 95% CI, 0.67 zuwa 0.89). An daidaita nau'ikan maganin hana ciwon daji na gaba tsakanin ƙungiyoyin jiyya.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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NAZARI

1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)

2.Zolbetuximab da CAPOX a cikin adenocarcinoma na ciki ko na gastroesophageal mai kyau na CLDN18.2: gwajin GLOW na lokaci na 3 | Maganin Yanayi

3.Zolbetuximab a cikin Mahadar Ciki ko Ciki ta Adenocarcinoma | Jaridar Magunguna ta New England (nejm.org)

4.Zolbetuximab da mFOLFOX6 a cikin marasa lafiya da ke fama da CLDN18.2-positive, HER2-negative, ba a yi musu magani ba, wanda ba a iya cirewa a gida ba, ko kuma wanda ba a iya cirewa ba, ko kuma wanda ya kamu da cutar kansa ta ciki ko ta hanji (SPOTLIGHT): gwaji na tsakiya da yawa, wanda aka yi bazuwar, wanda ba a iya gani ba, mataki na 3 - The Lancet