Disemba 20, 2024, Ụlọ Ọrụ Nlekọta Ngwaahịa Ahụike Mba nke China (NMPA) akwadola ojiji ọgwụ ọhụrụ (NDA) nke DOVBLERON® (taletrectinib adipate capsule), ọgwụ mgbochi ROS1 tyrosine kinase inhibitor (TKI) nke ọgbọ na-esote, maka ọgwụgwọ ndị okenye nwere ọrịa kansa akpa ume ROS1 nke dị elu ma ọ bụ nke na-abụghị obere mkpụrụ ndụ (NSCLC) nke a na-agwọbu na mbụ site na iji ROS1 TKIs.
Nkwenye a dabere na nsonaazụ dị mma sitere na nnwale TRUST-I nke Phase 2 (NCT04395677), nnwale otu aka nke nwere ọtụtụ etiti, nke mepere emepe, nke nyochachara taletrectinib na ndị ọrịa China nwere NSCLC dị elu nke nwere ROS1-positive. Nchọpụta ndị a, nke e gosipụtara na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke 2024 ma bipụta ya na Journal of Clinical Oncology (JCO), gosipụtara ike DOVBLERON® nwere iji lebara mkpa ndị a na-emezughị anya, karịsịa na ndị ọrịa nwere obere nhọrọ ọgwụgwọ mgbe ọgwụgwọ ya na ọgwụgwọ ndị e lekwasịrị anya na ROS1 gara aga.
Ruo na Nọvemba 29, 2023, ndị ọrịa China 173 (106 TKI na-enweghị; 67 crizotinib-pretreated) natara taletrectinib. N'ime ndị ọrịa 106 TKI na-enweghị, cORR nke IRC tụlere bụ 90.6% (95% CI, 83.33 ruo 95.38) yana ndị ọrịa anọ (3.8%) na-enweta CR na 92 (86.8%) na-enweta PR. DCR bụ 95.3% (95% CI, 89.33 ruo 98.45), na TTR nke etiti bụ ọnwa 1.4 (95% CI, 1.38 ruo 1.41). Site na nlekota nke etiti nke ọnwa 22.1 na ọnwa 23.5, erughi DOR ma ọ bụ PFS nke etiti; DOR na PFS nke ọnwa iri abụọ na anọ bụ 78.6% (95% CI, 66.86 ruo 86.56) na 70.5% (95% CI, 59.17 ruo 79.16), n'otu n'otu.
N'ime ndị ọrịa 66 e jiri crizotinib gwọọ tupu oge eruo, cORR nke IRC nyochachara bụ 51.5% (95% CI, 38.88 ruo 64.01) yana ndị ọrịa 34 (51.5%) na-enweta PR. DCR bụ 83.3% (95% CI, 72.13 ruo 91.38), na TTR nke etiti bụ ọnwa 1.4 (95% CI, 1.38 ruo 1.41). Site na ọnwa 8.4 na ọnwa 9.7 nke nleba anya, DOR nke etiti bụ ọnwa 10.6 (95% CI, 6.31 ruo na erughi [NR]), na PFS nke etiti bụ ọnwa 7.6 (95% CI, 5.52 ruo 11.96). Ọnụego DOR na PFS nke ọnwa itoolu bụ 69.8% (95% CI, 47.94 ruo 83.84) na 47.4% (95% CI, 33.50 ruo 60.02), n'otu n'otu. Ndị nyocha ahụ hụrụ nsonaazụ yiri nke ahụ.
Banyere DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® bụ ROS1 nke na-arụ ọrụ n'ọnụ, nke dị ike, nke na-arụ ọrụ n'ime akwara etiti, nke na-ahọrọ ihe, nke na-esote ọgbọ ROS1.
E mere ka ọgwụ mgbochi ahụ pụta ìhè maka ọgwụgwọ ndị ọrịa nwere NSCLC dị elu nke ROS1. A na-enyocha Taletrectinib, ihe na-arụ ọrụ na DOVBLERON ® maka ọgwụgwọ ndị ọrịa nwere NSCLC dị elu nke ROS1 na-arụ ọrụ na ọmụmụ ihe abụọ nke otu ogwe aka: TRUST-I (NCT04395677) na China, na TRUST-II (NCT04919811), ọmụmụ ihe zuru ụwa ọnụ.
Ọrịa kansa akpa ume ka na-enwe otu n'ime ọnụọgụgụ ndị kacha elu n'ụwa na ọnụọgụgụ ndị nwụrụ anwụ, ebe NSCLC na-aza ihe dị ka 85% nke ikpe niile. Na China, a na-eme atụmatụ na ihe dị ka 2.6% nke ndị ọrịa bi na NSCLC nwere ROS1-positive. Ọzọkwa, ọrịa ụbụrụ bụ ihe ịma aka a na-ahụkarị, na-emetụta ihe ruru 35% nke ndị ọrịa a chọpụtara ọhụrụ na ROS1-positive NSCLC, ma na-amụba ruo 55% nke ndị ọrịa kansa ha agaala n'ihu mgbe ọgwụgwọ mbụ gasịrị. Na mgbakwunye, ndị ọrịa a na-agwọ na ROS1 TKIs a kwadoro na-enwekarị mgbanwe iguzogide ọgwụgwọ ndị a, nke na-anọchite anya oke mmachi maka ndị ọrịa n'ihe gbasara oge nzaghachi. Nkwenye nke DOVBLERON® na-enye nhọrọ ọgwụgwọ ọhụrụ na nke dị irè maka ndị ọrịa na-anaghịzi anabata ọgwụgwọ ndị a kwadoro na mbụ.
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
Ozi ịntanetị:myimmnet@163.com
Ntụaka
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Nkwupụta Ndị Nkwukọrịta (innoventbio.com)
3.https://ascopubs.org/doi/10.1200/JCO.24.00731?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Oge ozi: Disemba-27-2024