NMPA kwadoro Senaparib maka ọgwụgwọ mmezi 1L na ọrịa kansa ovarian

Na Jenụwarị 16, 2025, IMPACT kwupụtara na Senaparib Capsules (派舒宁®) enwetala ikike ahịa na China site na National Medical Products Administration (NMPA) dị ka ọgwụgwọ otu maka ọgwụgwọ nlekọta nke ndị ọrịa toro eto nwere epithelial dị elu (FIGO Stages III na IV) nke nwere oke ovarian, fallopian tube ma ọ bụ kansa peritoneal mbụ bụ ndị na-aza (zuru oke ma ọ bụ akụkụ) mgbe emechara ọgwụgwọ chemotherapy nke dabere na platinum nke mbụ.

Senaparib, nke IMPACT chọpụtara ma mepụta, bụ ihe mgbochi PARP 1/2 dị ike ma dị ọhụrụ. Ọdịdị molekul ya pụrụ iche na-enye ya ọrụ dị elu na vitro na in vivo, nhọrọ ebumnuche pụrụ iche na windo nchekwa sara mbara. Nkwado a dabere na Ọmụmụ FLAMES. Ọmụmụ ihe a bụ ọmụmụ ahụike nke usoro atọ, nke a na-achịkwa nke ọma, nke a na-achịkwa site na placebo, nke a na-achịkwa site na ọtụtụ etiti, iji nyochaa irè na nchekwa nke Senaparib dị ka monotherapy maka ọgwụgwọ mmezi nke ndị ọrịa nwere kansa ovarian dị elu bụ ndị mechara chemotherapy mbụ ma nweta nzaghachi zuru oke (CR) ma ọ bụ nzaghachi akụkụ (PR). Nsonaazụ nke Ọmụmụ FLAMES gosiri na Senaparib gosipụtara mmụba dị ukwuu na PFS etiti ma e jiri ya tụnyere placebo (PFS erughi na ọnwa 13.6, HR 0.43, P < 0.0001), n'agbanyeghị ọnọdụ BRCA. Senaparib gosipụtara profaịlụ nchekwa a na-anabata, na-enweghị nsogbu nchekwa a na-ahụ anya. [1] Nsonaazụ ahụ gosikwara na ma ndị HRD dị mma na ndị na-adịghị mma na HRD nwetara uru site na ọgwụgwọ mmezi Senaparib, na-egosipụta ike nke Senaparib maka ojiji ahụike sara mbara. Nsonaazụ nke ọmụmụ ihe a ga-akwado Senaparib nke ọma dị ka Ụkpụrụ Nlekọta maka ọgwụgwọ nlekọta mbụ na ndị ọrịa nwere ọrịa kansa ovarian ọhụrụ achọpụtara.

E gosipụtara ihe ndị kacha pụta ìhè n'ọmụmụ ihe a na mbụ dị ka ihe ngosi ọnụ na-adịghị agwụ agwụ na ESMO na 2023 ma gosipụta ya na CSCO 2024. Na Mee 15, 2024, akwụkwọ akụkọ ahụike a ma ama n'ụwa niile bụ́ Nature Medicine bipụtakwara nsonaazụ ya nke akpọrọ "Senaparib dị ka ọgwụgwọ mmezi mbụ na kansa ovarian dị elu: nnwale nke usoro atọ a na-enweghị usoro."

Ọrịa kansa ovarian bụ otu n'ime ọrịa kansa ụmụ nwanyị kacha egbu egbu. Dịka data GLOBOCAN 2020 si kwuo, ọnụọgụgụ ọrịa kansa ovarian zuru ụwa ọnụ ruru 310,000, ọnwụ ya ruru 210,000. Dịka ọnụọgụgụ ọrịa kansa mba kachasị ọhụrụ nke National Cancer Center wepụtara na 2024 si kwuo, e nwere ọrịa kansa ovarian ọhụrụ 61,100 na ọnwụ 32,600 na China na 2022, nke mere ka ọ bụrụ ọrịa kansa ovarian kacha egbu egbu. N'ihi ihe mgbaàmà mbụ nke ọrịa kansa ovarian na-adịghị ahụkebe na nke na-abụghị kpọmkwem, ihe dị ka 80% nke ndị ọrịa abanyelarị n'ọkwa dị elu mgbe a chọpụtara ha, ọnụego ndụ afọ ise bụ naanị 41.8%. Ọ bụ ezie na enwere ike idozi ọrịa kansa ovarian mgbe ejiri ọgwụ chemotherapy nke nwere platinum mee ihe mbụ, ọtụtụ ndị ọrịa na-eche ihu nlọghachi ọzọ, a ka nwekwara mkpa ọgwụgwọ dị ukwuu maka ndị ọrịa kansa ovarian.

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

Email：myimmnet@163.com

Ntụaka

1.国家药品监督管理局 (nmpa.gov.cn)

2.https://www.prnewswire.com/news-releases/senaparib-approved-by-nmpa-for-1l-maintenance-therapy-in-ovarian-cancer-302353885.html