Nnabata nke Ngwa Akwụkwọ ikike Biologics maka TIVDAK maka Ọgwụgwọ Ndị Ọrịa Nwere Ọrịa Kansa Cervical Na-emegharị Anya ma Ọ Bụ Metastatic

Na Machị 12, 2025, Zai Lab Limited kwupụtara na National Medical Products Administration (NMPA) nke China anabatala Ngwa ikike Biologics (BLA) maka TIVDAK (tisotumab vedotin-tftv) maka ọgwụgwọ nke ndị ọrịa nwere kansa cervical ugboro ugboro ma ọ bụ nke gbawara agbawa nke nwere ọganihu ọrịa na ọgwụgwọ sistemụ ma ọ bụ mgbe ọgwụgwọ ahụ gasịrị.

Nsonaazụ sitere na nnwale ahụike zuru ụwa ọnụ nke InnovaTV 301 nke usoro 3 kwadoro ntinye BLA (NCT04697628) na nsonaazụ sitere na obere ọnụọgụgụ ndị China nke ọmụmụ ihe a.

Ngụkọta ndị ọrịa 502 mere usoro nhazi (e kenyere 253 na otu tisotumab vedotin na 249 na otu kemoterapi); otu ndị ahụ yiri onwe ha ma a bịa n'ihe gbasara njirimara ọnụọgụ mmadụ na ọrịa. Nduzi etiti zuru oke dị ogologo karịa na otu tisotumab vedotin karịa na otu kemoterapi (ọnwa 11.5 [oge ntụkwasị obi 95% {CI}, 9.8 ruo 14.9] vs. ọnwa 9.5 [95% CI, 7.9 ruo 10.7]), nsonaazụ nke gosipụtara obere ihe egwu ọnwụ na tisotumab vedotin karịa na kemoterapi (oke ihe egwu, 0.70; 95% CI, 0.54 ruo 0.89; P-akụkụ abụọ = 0.004). Ndakpọ ndụ nke etiti n'enweghị ọganihu bụ ọnwa 4.2 (95% CI, 4.0 ruo 4.4) na tisotumab vedotin na ọnwa 2.9 (95% CI, 2.6 ruo 3.1) na kemoterapi (oke ihe ize ndụ, 0.67; 95% CI, 0.54 ruo 0.82; P nwere akụkụ abụọ <0.001). Ọnụego nzaghachi ebumnuche akwadoro bụ 17.8% na otu tisotumab vedotin na 5.2% na otu kemoterapi (oke ihe ndabara, 4.0; 95% CI, 2.1 ruo 7.6; P nwere akụkụ abụọ <0.001). Ngụkọta nke 98.4% nke ndị ọrịa nọ na otu tisotumab vedotin na 99.2% na otu kemoterapi nwere opekata mpe otu ihe ọjọọ nke mere n'oge ọgwụgwọ (akọwapụtara dị ka oge site na ụbọchị 1 nke dose 1 ruo ụbọchị 30 mgbe dose ikpeazụ gasịrị); Ihe omume nke ọkwa nke atọ ma ọ bụ karịa mere na 52.0% na 62.3%, n'otu n'otu. Ngụkọta nke 14.8% nke ndị ọrịa kwụsịrị ọgwụgwọ tisotumab vedotin n'ihi mmetụta ọjọọ.

Banyere TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) bụ njikọ ọgwụ mgbochi-ọgwụ (ADC) nke mejupụtara ọgwụ mgbochi monoclonal nke Genmab nke a na-eduzi na ihe dị n'ime anụ ahụ (TF) na teknụzụ ADC nke Pfizer nke na-eji njikọ protease-cleavable nke na-ejikọ ihe na-akpata microtubule-disrupting monomethyl auristatin E (MMAE) na antibody. Data ndị na-abụghị nke ahụike na-egosi na ọrụ anticancer nke tisotumab vedotin bụ n'ihi njikọ nke ADC na mkpụrụ ndụ kansa na-egosipụta TF, wee sochie ime nke ADC-TF complex, na ntọhapụ nke MMAE site na proteolytic cleavage. MMAE na-emebi netwọk microtubule nke mkpụrụ ndụ na-ekewa nke ọma, na-eduga na njide okirikiri sel na ọnwụ mkpụrụ ndụ apoptotic. Na vitro, tisotumab vedotin na-akwalitekwa phagocytosis sel dabere na antibody na cytotoxicity sel dabere na antibody.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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Ntụaka

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.zailaboratory.com/

3.Tisotumab Vedotin dị ka Ọgwụgwọ nke Abụọ ma ọ bụ nke Atọ maka Ọrịa Kansa Cervical Na-agagharị | New England Journal of Medicine (nejm.org)