Ụlọ Ọrụ Ọgwụ Mba nke China kwadoro Zepzelca (lubbinectedin maka ịgba ọgwụ) maka ọgwụgwọ kansa akpa ume nke obere mkpụrụ ndụ.

Na Disemba 3, 2024, a kwadoro ọgwụ ọhụrụ Zepzelca (lubbinectedin maka ịgba ọgwụ) maka ire ahịa site na National Medical Products Administration (NMPA) site na mmemme nyocha mbụ. A na-enye ọgwụ a maka ọgwụgwọ ndị okenye nwere kansa akpa ume obere mkpụrụ ndụ (SCLC) nke nwere ọganihu ọrịa na ma ọ bụ mgbe ejiri ọgwụ chemotherapy dabere na platinum mee ihe.

Zepzelca bụ ọgwụ na-egbochi mkpụrụ ndụ kansa. Ọ bụ ezie na ọ na-egbochi mkpụrụ ndụ kansa, ọ na-achịkwa gburugburu ebe obibi maka etuto ahụ ma na-eduga na apoptosis nke mkpụrụ ndụ kansa. US Food and Drug Administration (FDA) kwadoro ọgwụ a site na Mmemme Nkwado Accelerated ya na 2020. Ruo afọ 27, ọ bụ naanị kemịkalụ ọhụrụ FDA kwadoro maka ọgwụgwọ nke SCLC laghachiri azụ kemgbe 1997.

NMPA kwadoro Zepzelca site na nsonaazụ nke ọmụmụ ihe abụọ dị mkpa. Otu n'ime ha bụ ọmụmụ ihe dị mkpa emere na mba ofesi, ọmụmụ ihe mepere emepe, multicenter, na otu aka (nnwale nkata nke Phase 2) na ndị okenye nwere SCLC (gụnyere ma ndị ọrịa nwere mmetụta platinum na ndị na-eguzogide platinum) bụ ndị nwere ọganihu ọrịa mgbe ha natara ọgwụgwọ chemotherapy dabere na platinum. N'ọmụmụ ihe a, e jiri Zepzelca gwọọ ha naanị site na ntinye ọgwụ ahụ n'ime akwara kwa izu atọ na dose nke 3.2 mg/m2. E bipụtara ọmụmụ ihe a na The Lancet Oncology, nke gosipụtara ọnụego nzaghachi zuru oke (ORR) nke 35.2%, oge nzaghachi etiti (mDoR) nke ọnwa 5.3, ndụ na-enweghị ọganihu etiti (mPFS) nke ọnwa 3.5, na mOS nke ọnwa 9.3 maka ndị ọrịa niile ejiri Zepzelca gwọọ. Ọmụmụ ihe ọzọ bụ ọmụmụ ihe otu aka, nke jikọtara ọnụ na mmụba na mmụba nke dose maka Zepzelca iji nyochaa nchekwa ya, nnabata ya, pharmacokinetics (PK), na irè mbụ ya na ndị ọrịa China nwere etuto siri ike dị elu, gụnyere SCLC na-emegharị ugboro ugboro. Ọmụmụ ihe ahụ gosiri ORR nke 45.5%, mDoR nke ọnwa 4.2, mPFS nke ọnwa 5.6 na mOS nke ọnwa 11.0 maka ndị ọrịa SCLC ejiri Zepzelca gwọọ site na infusion intravenous kwa izu atọ na dose nke 3.2 mg/m2.
Ọmụmụ ihe abụọ a dị n'elu gosiri ọrụ dị mkpa maka igbochi etuto ahụ maka Zepzelca dị ka ọgwụgwọ nke abụọ maka SCLC nwere profaịlụ nchekwa a na-achịkwa. Na mgbakwunye, ọmụmụ ihe emere n'etiti ndị China gosipụtara nsonaazụ ka mma nke ndị ọrịa.
Ọzọkwa, a na-enyocha Zepzelca n'ọtụtụ nnwale ahụike mba ụwa. N'ọmụmụ nke Usoro nke 1/2, Zepzelca na atezolizumab gosipụtara ORR nke 66.67%, mPFS nke ọnwa 4.7, na mOS nke ọnwa 14.5 mgbe ejiri ya dị ka ọgwụgwọ nke abụọ maka ndị ọrịa nwere SCLC dị elu. N'ọmụmụ nke Usoro nke 1/2 ọzọ, Zepzelca jikọtara ya na pembrolizumab gosipụtara ORR nke 46.4%, mPFS nke ọnwa 5.3, na mOS nke ọnwa 11.1 dị ka ọgwụgwọ nke abụọ maka ndị ọrịa nwere SCLC ọzọ. Ọzọkwa, ọmụmụ ihe gbasara ahụike metụtara Zepzelca na njikọta ya na ihe mgbochi nchebe ahụ dị ka ọgwụgwọ mmezi nke mbụ maka SCLC, yana chemotherapy maka ọgwụgwọ nke SCLC ọzọ, yana maka ọgwụgwọ leiomyosarcoma na-agakwa n'ihu. Emebere ọmụmụ ihe ndị a iji nọgide na-enyocha ojiji ahụike na ikike ọgwụgwọ nke ọgwụ ahụ.

Ruo ugbu a, a nabatala Zepzelca maka ire ahịa na mba na mpaghara iri na asaa n'ụwa niile. A na-enye Luye Pharma ikike ịmepụta ma ree ọgwụ a na mpaghara China, Hong Kong, na Macao, ma enwetala ikike ire ahịa maka ọgwụ a na mpaghara atọ ndị a.

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

1.2024年12月03日药品批准证明文件送达信息 (nmpa.gov.cn)

2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® (luye.cn)