ʻO CStone Pharmaceuticals, kahi hui biopharmaceutical i kālele ʻia i ka noiʻi, hoʻomohala ʻana, a me ka hoʻolaha ʻana o nā immuno-oncology therapies hou a me nā lāʻau lapaʻau pololei, ua hoʻolaha i kēia lā i ka noi lāʻau hou (NDA) no pralsetinib no ka mālama ʻana i ka hoʻoponopono hou ʻana i ka wā transfection (RET) fusion-positive kūloko. Ua ʻae ʻia ka maʻi maʻi ʻaʻai ʻana o ka maʻi maʻi maʻi maʻi ʻaʻole liʻiliʻi (NSCLC) ma Hong Kong, Kina.
ʻO Pralsetinib kahi mea hoʻopale RET ikaika a koho i ʻike ʻia e ka hoa o CStone Blueprint Medicines. He hui kūʻokoʻa ko CStone a me ka ʻaelike laikini me Blueprint Medicines no ka hoʻomohala ʻana a me ka hoʻolaha ʻana o pralsetinib ma Greater China, e hoʻopuni ana iā Mainland China, Hong Kong, Macau a me Taiwan.
Ua ʻōlelo ʻo Kauka Jason Yang, Luna Nui o CStone, "Ua hauʻoli nui mākou i ka ʻae ʻia ʻana o ka NDA o kekahi lāʻau lapaʻau precision hou, pralsetinib, no ka mālama ʻana i ka RET fusion-positive NSCLC kiʻekiʻe, ma hope o ka ʻae ʻia ʻana o AYVAKIT® (avapritinib). no ka mālama ʻana i nā maʻi maʻi ʻaʻa ʻole o ka PDGFRA D842V mutant gastrointestinal stromal ma Hong Kong, Kina i Dekemaba 2021. Ma ka pae honua 1/2 ARROW haʻawina, ua hōʻike ʻo pralsetinib i nā pono lapaʻau lōʻihi a me kahi ʻano palekana palekana maʻamau i nā maʻi me RET fusion. - maikaʻi kūloko kūloko a i ʻole metastatic NSCLC. Ke kakali nei mākou i ka hiki ke ʻae ʻia o pralsetinib ma Hong Kong, Kina e kōkua i ka pōmaikaʻi hou aku i nā maʻi i ka wikiwiki.
Hoʻokumu ʻia ka ʻae ʻana o NDA i ka pralsetinib ma Hong Kong, Kina ma nā hopena mai ka pae honua 1/2 ARROW study. Hoʻolālā ʻia kēia hoʻāʻo e loiloi i ka palekana, ka ʻae ʻana, a me ka maikaʻi o ka pralsetinib i nā poʻe maʻi me ka RET-fusion positive NSCLC, RET-mutant medullary thyroid cancer (MTC), a me nā maʻi ʻokoʻa paʻa ʻē aʻe me ka RET fusions.
Ua hōʻike ʻia nā hopena mai ka hoʻāʻo ARROW i nā maʻi maʻi honua me RET fusion-positive NSCLC kiʻekiʻe i ka 2021 American Society of Clinical Oncology (ASCO) Annual Meeting ma Iune 2021. Ma kahi lā ʻoki ʻia o Nowemapa 6, 2020, ua hōʻike ʻo pralsetinib i ka lāʻau lapaʻau paʻa. Loaʻa nā pōmaikaʻi i nā maʻi me ka RET fusion-positive NSCLC i loaʻa i ka maʻi hiki ke ana ma ka papa kuhikuhi a loaʻa iā ia kahi maʻi hoʻomaka o 400 mg hoʻokahi i kēlā me kēia lā.
• I loko o 68 maʻi lapaʻau-naïve, ka huina pane helu (ORR) he 79 pakeneka (95% CI: 68%, 88%). ʻO ka helu pane piha (CR) he 6 pākēneka, 10 pākēneka o nā maʻi i hoʻihoʻi piha i nā maʻi maʻi i hoʻopaʻa ʻia, a ʻo 74 pākēneka o nā maʻi i loaʻa kahi pane hapa (PR). ʻAʻole i hiki i ka lōʻihi o ka pane (DOR) (95% CI: 9.0 mahina, ʻaʻole i hiki).
• I nā maʻi 126 i loaʻa mua i ka chemotherapy e pili ana i ka platinum, ʻo ka ORR he 62 pakeneka (95% CI: 53%, 70%). ʻO ka helu CR he 4 pākēneka, 12 pākēneka o nā maʻi i hoʻihoʻi piha i nā maʻi maʻi i hoʻopaʻa ʻia, a he 58 pākēneka o nā maʻi i loaʻa kahi PR. ʻO ka median DOR he 22.3 mahina (95% CI: 15.1 mahina, ʻaʻole i hiki).
• E like me ka lā oki ʻikepili, ua hoʻopaʻa inoa ʻia he 471 mau maʻi ma waena o nā ʻano tumo me kahi ʻano pralsetinib e hoʻomaka ana ma 400 mg hoʻokahi i kēlā me kēia lā. ʻO nā hanana ʻino e pili ana i ka lāʻau maʻamau (AEs) i hōʻike ʻia e nā mea noiʻi, ʻo ia ka neutropenia, hoʻonui aspartate aminotransferase, anemia, hoʻemi i ka helu keʻokeʻo keʻokeʻo, hoʻonui alanine aminotransferase, hypertension, constipation a me asthenia.
He aha e lawe ʻia mai kēia ʻatikala:
- Jason Yang, Chief Medical Officer of CStone, said, “We are very glad that the NDA of another innovative precision medicine, pralsetinib, is accepted for the treatment of advanced RET fusion-positive NSCLC, after AYVAKIT® (avapritinib) was approved for the treatment of unresectable or metastatic PDGFRA D842V mutant gastrointestinal stromal tumors in Hong Kong, China in December 2021.
- As of a date cutoff date of November 6, 2020, pralsetinib showed durable clinical benefits in patients with RET fusion-positive NSCLC who had measurable disease at baseline and received a starting dose of 400 mg once daily.
- ʻO CStone Pharmaceuticals, kahi hui biopharmaceutical i kālele ʻia i ka noiʻi, hoʻomohala ʻana, a me ka hoʻolaha ʻana o nā immuno-oncology therapies hou a me nā lāʻau lapaʻau pololei, ua hoʻolaha i kēia lā i ka noi lāʻau hou (NDA) no pralsetinib no ka mālama ʻana i ka hoʻoponopono hou ʻana i ka wā transfection (RET) fusion-positive kūloko. Ua ʻae ʻia ka maʻi maʻi ʻaʻai ʻana o ka maʻi maʻi maʻi maʻi ʻaʻole liʻiliʻi (NSCLC) ma Hong Kong, Kina.
