Anti-PD-L1 (Tagitanlima) Natara Nkwado NMPA maka Ahịa

Na Disemba 31, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Ụlọ ọrụ ahụ") enwetala ikike ahịa na China site n'aka National Medical Products Administration (NMPA) maka ọgwụ mgbochi monoclonal ọhụrụ nke a na-akpọ "mAb" (PD-L1) nke a na-eduzi maka ọgwụgwọ nke ndị ọrịa nwere kansa nasopharyngeal ugboro ugboro ma ọ bụ metastatic (NPC) ndị dara ada mgbe ha nwetasịrị chemotherapy 2L+ tupu oge ahụ. Nke a bụ ọgwụ mgbochi monoclonal mbụ nke PD-L1 nke a kwadoro maka ọgwụgwọ NPC.

Nkwenye a dabere na nnyocha ahụike nke otu aka, ọtụtụ etiti, nke usoro nke abụọ na ndị ọrịa nwere NPC ugboro ugboro ma ọ bụ nke metastatic bụ ndị dara ada mgbe ọgwụgwọ usoro 2L+ gara aga gasịrị, nke Prọfesọ Shi Yuankai nke Cancer Hospital Chinese Academy of Medical Sciences duziri dịka onye nyocha bụ isi, iji nyochaa irè na profaịlụ nchekwa nke tagitanlimab monotherapy.

N'agbata Febụwarị 26, 2019 na Jenụwarị 13, 2021, a gwọrọ ndị ọrịa 153. N'ozuzu, ndị ọrịa 132 banyere na nhazi nyocha zuru oke (FAS) ma nyochaa maka irè ya. Dịka ụbọchị njedebe data na Julaị 13, 2021, oge nleba anya etiti bụ ọnwa 21.7 (95%CI 19.8–22.5). Maka ọnụọgụ FAS, ORR nke IRC tụlere bụ 26.5% (95%CI 19.2–34.9%), ọnụego njikwa ọrịa (DCR) bụkwa 56.8% (95%CI 47.9–65.4%). Nlanarị etiti enweghị ọganihu (PFS) bụ ọnwa 2.8 (95%CI 1.5–4.1). Oge etiti nke nzaghachi bụ ọnwa 12.4 (95%CI 6.8–16.5), ebe etiti ogologo ndụ (OS) bụ ọnwa 16.2 (95%CI 13.4–21.3).

Banyere NPC

Data GLOBOCAN nke afọ 2022 gosiri na e nwere ihe karịrị mmadụ 120,000 ọhụrụ nwere ọrịa kansa nasopharyngeal n'ụwa niile, mmadụ 51,000 ọhụrụ nwere ọrịa kansa nasopharyngeal na ọnwụ 28,400 na China. Dịka ntuziaka CSCO nke afọ 2021 si dị, usoro ọgwụgwọ 1L maka ọrịa kansa nasopharyngeal na-adịghị agwọ ọrịa ma ọ bụ nke na-adịghị agwọ ọrịa dabere na ọgwụ kemịkalụ nke nwere platinum, ọgwụgwọ 2L dabere na ọgwụgwọ otu. Ọnụọgụ ndụ afọ 5 nke ndị ọrịa nwere ọrịa kansa nasopharyngeal na-agagharị agagharị ma ọ bụ nke na-agafe agafe bụ 18.5%, yana OS etiti nke ọnwa 22.1, a ka nwere mkpa ahụike a na-emezughị iji melite uru ahụike nke otu ndị ọrịa a, ọkachasị ndị na-ebute metastases mgbe ọgwụgwọ gasịrị. N'afọ ndị na-adịbeghị anya, ọgwụgwọ immunotherapy enyela ọtụtụ nhọrọ ọgwụgwọ maka ndị ọrịa kansa ma ghọọ ụzọ dị irè isi gwọọ ndị ọrịa nwere kansa nasopharyngeal.

Banyere Tagitanlima

Tagitanlima, nke Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China) mepụtara, bụ ọgwụ mgbochi IgG1κ monoclonal zuru oke nke na-elekwasị anya na PD-L1 nke na-egbochi mmekọrịta nke PD-L1 na PD-1 nke ọma.

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.

Nọmba ekwentị: 4008803716

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Ntụaka

1.Teknụzụ na Ọdụ Ngwaahịa – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

2.国家药监局批准塔戈利单抗注射液上市 (nmpa.gov.cn)

3.Ịrụ ọrụ na nchekwa nke KL-A167 na kansa nasopharyngeal nke a na-agwọbu ma ọ bụ nke metastatic: ọmụmụ ihe nke abụọ nke ngalaba, otu aka, nke dị n'etiti - Ahụike Mpaghara Lancet - Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet (London, England) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.