Kamfanin Limertinib ya sami amincewar China kan EGFR T790M+ NSCLC

A ranar 16 ga Janairu, 2025, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da amfani da sabon magani (NDA) na limertinib don maganin manya da ke fama da cutar kansar huhu ta EGFR T790M da aka canza ta hanyar ƙwayoyin cuta (NSCLC) ko kuma ta yaɗuwa.

Game da Limertinib

Limertinib magani ne na EGFR TKI wanda aka sarrafa ta baki, wanda aka yi shi da ƙarni na uku, wanda ke da haƙƙin mallakar mallaka, wanda NMPA ta China ta amince da shi don maganin manyan marasa lafiya da suka kamu da cutar kansar huhu ta EGFR T790M mai canzawa a cikin gida ko kuma waɗanda suka kamu da cutar kansar huhu ta ƙananan ƙwayoyin halitta (NSCLC). Ana yin bita na biyu na NDA don maganin farko na manya da suka kamu da cutar NSCLC mai ci gaba a cikin gida ko waɗanda suka kamu da cutar da ke ɗauke da maye gurbin EGFR exon 19 ko maye gurbin exon 21 L858R.

Maganin ya nuna nasara a wani gwaji na asibiti mai ci gaba da yawa, wanda bazuwar, makanta biyu, wanda aka sarrafa a mataki na 3, wanda aka kwatanta ingancinsa da amincinsa ga gefitinib a cikin maganin farko ga marasa lafiya da suka kamu da cutar NSCLC ta hanyar gida ko kuma waɗanda suka kamu da cutar da ke ɗauke da maye gurbi na EGFR. Da zarar an cimma matsaya ta farko, za a gabatar da sakamakon a tarurrukan ilimi masu zuwa ko kuma a buga su a mujallun ilimi.

An sami goyon bayan shawarar da aka yanke ta hanyar bayanai daga wani gwaji mai mahimmanci na mataki na 2b (NCT03502850). Wannan wani bincike ne na hannu ɗaya, mai lakabin budewa, na mataki na 2b wanda aka gudanar a asibitoci 62 a faɗin Jamhuriyar Jama'ar China. An yi wa marasa lafiya da suka kamu da cutar NSCLC mai ci gaba a cikin gida ko kuma waɗanda suka kamu da cutar NSCLC mai ci gaba a tsakiya ko kuma waɗanda suka kamu da cutar a cikin jini bayan an yi musu maganin hana EGFR tyrosine kinase na ƙarni na farko ko na biyu ko kuma waɗanda suka kamu da cutar EGFR T790M na farko.

Daga ranar 16 ga Yuli, 2019, zuwa 10 ga Maris, 2021, jimillar marasa lafiya 301 ne suka yi rajista kuma suka fara maganin limertinib. Duk marasa lafiya sun shiga cikakken tsarin bincike da saitin aminci. Kafin ranar yanke bayanai a ranar 9 ga Satumba, 2021, 76 (25.2%) sun ci gaba da shan magani. Matsakaicin lokacin bin diddigin shine watanni 10.4. Dangane da cikakken tsarin bincike, ORR mai zaman kansa wanda kwamitin bita ya tantance shine 68.8% kuma ƙimar kula da cututtuka shine 92.4%. Matsakaicin PFS shine watanni 11.0, matsakaicin DoR shine watanni 11.1, kuma ba a cimma matsakaicin tsarin aiki ba. An cimma amsoshi masu ma'ana a duk ƙananan ƙungiyoyi da aka ƙayyade. Ga marasa lafiya 99 (32.9%) da suka kamu da cutar ta hanyar tsarin jijiyoyi na tsakiya (CNS), ORR ya kasance 64.6%, matsakaicin PFS shine watanni 9.7 (95% CI: 5.9–11.6), kuma matsakaicin DoR shine watanni 9.6. Ga marasa lafiya 41 waɗanda suka sami rauni na CNS da za a iya tantancewa, CNS-ORR da aka tabbatar shine 56.1% kuma matsakaicin CNS-PFS shine watanni 10.6.

A cikin tsarin aminci, marasa lafiya 289 (96.0%) sun fuskanci aƙalla mummunan sakamako guda ɗaya da ya shafi magani (TRAE), waɗanda suka fi yawa sune gudawa (81.7%), anemia (32.6%), kuraje (29.9%), da anorexia (28.2%). TRAEs na aji ≥3 sun faru a cikin marasa lafiya 104 (34.6%), waɗanda suka fi yawa sun haɗa da gudawa (13.0%), hypokalemia (4.3%), anemia (4.0%), da kuraje (3.3%). TRAEs waɗanda suka haifar da katsewar allurai da dakatar da allurai sun faru a cikin 24.6% da 2% na marasa lafiya, bi da bi. Babu TRAE da ya kai ga mutuwa.

Kammalawa

An gano cewa Limertinib (ASK120067) yana da tasiri mai kyau da kuma ingantaccen bayanin aminci don maganin marasa lafiya da suka kamu da cutar NSCLC mai canzawa ta EGFR T790M.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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Nassoshi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Kamfanin Magunguna na Jiangsu Aosaikang (ASK Pharm) (ask-pharm.com)

3.Kamfanin Innovent da ASK Pharm Sun Sanar da Amincewa da NMPA ga Limertinib, wani maganin EGFR na ƙarni na uku don maganin cutar kansar huhu (prnewswire.com)

4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext