A ranar 20 ga Disamba, 2024, Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta amince da amfani da sabon magani (NDA) na DOVBLERON® (taletrectinib adipate capsule), wani maganin hana tyrosine kinase na ROS1 (TKI) na zamani, don magance manyan marasa lafiya da ke fama da cutar kansar huhu ta ROS1-positive non-small cell (NSCLC) da ta bulla a yankinsu ko kuma ta bazu a yankinsu, wadanda aka yi musu magani da ROS1 TKIs a baya.
Amincewar ta dogara ne akan sakamako mai kyau daga gwajin TRUST-I na Mataki na 2 (NCT04395677), wani gwaji mai cibiya da yawa, mai lakabin hannu ɗaya wanda ya kimanta taletrectinib a cikin marasa lafiya na China waɗanda ke da ci gaba da ROS1-positive NSCLC. Sakamakon binciken, wanda aka gabatar a taron shekara-shekara na American Society of Clinical Oncology (ASCO) na 2024 kuma aka buga a cikin Mujallar Clinical Oncology (JCO), ya nuna yuwuwar DOVBLERON® don magance buƙatun da ba a cika ba, musamman a cikin marasa lafiya da ke da ƙarancin zaɓuɓɓukan magani bayan magani da magungunan da aka yi niyya ga ROS1 a baya.
Ya zuwa ranar 29 ga Nuwamba, 2023, marasa lafiya 173 na kasar Sin (106 TKI ba su da lafiya; 67 da aka yi wa magani kafin a fara amfani da su) sun sami taletrectinib. Daga cikin marasa lafiya 106 da aka yi wa magani kafin a fara amfani da su, an yi wa IRC gwajin cORR kashi 90.6% (95% CI, 83.33 zuwa 95.38) tare da marasa lafiya hudu (3.8%) da suka samu CR da kuma 92 (86.8%) da suka samu PR. DCR ya kasance kashi 95.3% (95% CI, 89.33 zuwa 98.45), kuma matsakaicin TTR ya kasance watanni 1.4 (95% CI, 1.38 zuwa 1.41). Tare da matsakaicin bin diddigin watanni 22.1 da watanni 23.5, ba a kai matsakaicin DOR ko matsakaicin PFS ba; DOR na watanni 24 da PFS sun kasance 78.6% (95% CI, 66.86 zuwa 86.56) da kuma 70.5% (95% CI, 59.17 zuwa 79.16), bi da bi.
Daga cikin marasa lafiya 66 da aka yi wa magani kafin a yi musu magani, an tantance cORR da aka yi wa IRC shine 51.5% (95% CI, 38.88 zuwa 64.01) tare da marasa lafiya 34 (51.5%) sun sami PR. DCR shine 83.3% (95% CI, 72.13 zuwa 91.38), kuma matsakaicin TTR shine watanni 1.4 (95% CI, 1.38 zuwa 1.41). Tare da watanni 8.4 da watanni 9.7 na bin diddigin, matsakaicin DOR shine watanni 10.6 (95% CI, 6.31 zuwa ba a kai ga [NR] ba), kuma matsakaicin PFS shine watanni 7.6 (95% CI, 5.52 zuwa 11.96). Adadin DOR da PFS na watanni 9 sun kasance 69.8% (95% CI, 47.94 zuwa 83.84) da 47.4% (95% CI, 33.50 zuwa 60.02), bi da bi. An ga irin wannan sakamako lokacin da masu bincike suka tantance shi.
Game da DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® magani ne mai ƙarfi, mai aiki da tsarin jijiyoyi na tsakiya, mai zaɓe, mai amfani da ROS1 na gaba.
An tsara maganin hana ƙwayoyin cuta musamman don maganin marasa lafiya da ke da ROS1-positive NSCLC. Ana tantance sinadarin Taletrectinib, wanda ke aiki a cikin DOVBLERON ® don maganin marasa lafiya da ke da ROS1-positive NSCLC a cikin nazarin matakai biyu na hannu ɗaya: TRUST-I (NCT04395677) a China, da TRUST-II (NCT04919811), wani bincike na duniya.
Ciwon daji na huhu yana ci gaba da kasancewa ɗaya daga cikin manyan abubuwan da suka faru da mace-mace a duniya, inda NSCLC ke da kusan kashi 85% na dukkan lamuran. A China, an kiyasta cewa kusan kashi 2.6% na marasa lafiya da ke zaune tare da NSCLC suna da ROS1-positive. Bugu da ƙari, ciwon kwakwalwa ƙalubale ne da aka saba fuskanta, yana shafar har zuwa kashi 35% na marasa lafiya da aka gano suna da ROS1-positive NSCLC, kuma yana ƙaruwa zuwa kashi 55% na marasa lafiya waɗanda ciwon daji ya ci gaba bayan magani na farko. Bugu da ƙari, marasa lafiya da aka yi wa magani da ROS1 TKIs da aka amince da su sau da yawa suna haifar da maye gurbi ga waɗannan hanyoyin magani, wanda ke wakiltar babban ƙuntatawa ga marasa lafiya dangane da tsawon lokacin amsawa. Amincewar DOVBLERON® tana ba da sabon zaɓi kuma mai tasiri ga marasa lafiya waɗanda ba sa amsawa ga magungunan da aka amince da su a baya.
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.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Sanarwar manema labarai (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
Lokacin Saƙo: Disamba-27-2024