Ua hoʻolaha ʻo CStone Pharmaceuticals i kēia lā ua ʻae ka National Medical Products Administration (NMPA) o Kina i ka palapala noi lāʻau hou hou (sNDA) o ka RET inhibitor GAVRETO® (pralsetinib) koho no ka mālama ʻana i ka RET-mutant medullary thyroid cancer (MTC) a me RET fusion. -ka maʻi maʻi thyroid maikaʻi (TC). Ua hoʻonui ka ʻae ʻia i nā hōʻailona o GAVRETO ma Kina e hoʻokomo i nā mea maʻi makua a me nā keiki maʻi 12 mau makahiki a ʻoi aku me ka MTC kiʻekiʻe a i ʻole metastatic RET-mutant e koi ana i ka systemic therapy, a me nā poʻe maʻi makua a me nā keiki maʻi he 12 mau makahiki a ʻoi aku me ka holomua a metastatic paha. RET fusion-positive TC e koi ana i ka lāʻau ʻōnaehana a me ka radioactive iodine-refractory (inā kūpono ka lāʻau iodine radioactive).

ʻIke ʻia e ka hoa o CStone Blueprint Medicines, ʻo GAVRETO kahi mea hoʻopaneʻe RET ikaika a koho. He hui kūʻokoʻa ko CStone a me ka ʻaelike laikini me Blueprint Medicines no ka hoʻomohala ʻana a me ke kālepa ʻana o GAVRETO ma Greater China, e hoʻopuni ana i Mainland China, Hong Kong, Macau a me Taiwan.

Ua ʻōlelo ʻo Kauka Frank Jiang, Luna Hoʻokele a me Luna Nui o CStone, "Ua hauʻoli nui mākou i ka ʻae ʻana o sNDA o GAVRETO, e hāʻawi i kahi koho lapaʻau hou no nā poʻe maʻi Kina me ka RET-mutant medullary thyroid cancer a me RET fusion-positive thyroid cancer. . Makemake mākou e hoʻonui i kā mākou mahalo kūikawā i ka NMPA no ka loiloi mua. Kūpaʻa mau ʻo CStone i ka hoʻomohala ʻana i nā lāʻau lapaʻau hou e hoʻoponopono i nā pono olakino i kūpono ʻole o nā maʻi maʻi maʻi. E hoʻomau mākou i ka hoʻomaikaʻi ʻana i ka waiwai lapaʻau a me ka hiki o kā mākou pipeline, a e hoʻoikaika i nā hana e hoʻolako i nā maʻi ma ka honua holoʻokoʻa me nā lāʻau lapaʻau kiʻekiʻe.

Ua ʻōlelo ʻo Polofesa Ming Gao, he mea noiʻi nui o ka noiʻi ARROW a me Pelekikena o Tianjin Union Medical Center, "Ua piʻi ka nui o ka nui o ka maʻi maʻi thyroid i nā makahiki i hala. Loaʻa nā koho lapaʻau liʻiliʻi no ka mālama ʻana i ka MTC, a aia kahi koi wikiwiki no nā lāʻau lapaʻau pololei, ʻoi aku hoʻi no nā poʻe maʻi me RET-mutant MTC. Ua hōʻike ʻo GAVRETO i ka hana anti-tumor ikaika a paʻa i nā poʻe maʻi Kina me ka MTC kiʻekiʻe a i ʻole metastatic RET-mutant MTC, me ka palekana holoʻokoʻa e kūlike me nā hopena i ʻike ʻia ma ka noiʻi ARROW honua. Me kēia hoʻonui ʻana o nā hōʻailona hōʻailona o GAVRETO, ke kakali nei mākou i ka hoʻoponopono ʻana i nā pono lapaʻau ʻole o nā maʻi maʻi maʻi thyroid.

Ua ʻōlelo ʻo Dr. Jason Yang, Luna Nui o CStone, "ʻO ka ʻae ʻana o NMPA i ka sNDA he mea nui hou ia no mākou ma hope o ka ʻae ʻia ʻana o GAVRETO no ka mālama ʻana i nā maʻi me ka maʻi maʻi maʻi kūloko a i ʻole metastatic RET fusion-positive non-liʻiliʻi maʻi pūpū. . Makemake mākou e hoʻomaikaʻi i nā mea maʻi a me nā mea noiʻi i hāʻawi i ke aʻo ʻana o GAVRETO i nā hōʻailona hoʻonui. E hoʻomau mākou i ka hoʻomau ʻana i ka noiʻi lapaʻau o GAVRETO no ka mālama ʻana i nā ʻano maʻi maʻi he nui i hiki iā mākou ke lawe koke i kēia lāʻau lapaʻau e kōkua i ka pōmaikaʻi i nā maʻi hou aʻe.

Hoʻokumu ʻia ka ʻae ʻana o ka sNDA ma nā hopena mai ka hoʻāʻo ʻana o ka pae honua 1/2 ARROW, i hoʻolālā ʻia e loiloi i ka palekana, ka hoʻomanawanui a me ka pono o GAVRETO i nā poʻe maʻi me RET fusion-positive NSCLC, RET-mutant MTC, a me nā maʻi koko paʻa kiʻekiʻe me nā RET fusions. . Ma kahi lā ʻoki ʻikepili o ʻApelila 12, 2021, he 28 mau mea maʻi me RET-mutant MTC kiʻekiʻe i hoʻopaʻa inoa ʻia i loko o ka hui hoʻopaʻa inoa hoʻopaʻa inoa ʻo China MTC o ke aʻo ARROW honua, a loaʻa iā ia kahi maʻi GAVRETO hoʻomaka o 400mg i kēlā me kēia lā. Ua hōʻike nā hopena noiʻi ʻo 26% ka mea i hoʻopaʻa ʻia i ka helu pane pane (ORR) o 73.1 RET-mutant MTC me nā maʻi hiki ke ana ʻia ma ka papa kuhikuhi, me 3 me ka pane piha (CR) a me 16 me nā pane hapa (PR). ʻO 84.6% ka helu hoʻomalu maʻi (DCR), a ua nānā ʻia nā pane me ka nānā ʻole i ka genotype mutation RET. Ma waena o nā maʻi 19 me ka pane i hoʻopaʻa ʻia, ʻaʻole i loaʻa ka lōʻihi o ka pane (DOR), a ʻo ka helu DOR 9 mau mahina he 100%. Ua hoʻemi nui ʻia nā pae Calcitonin a me carcinoembryonic antigen (CEA). Ua ʻae maikaʻi ʻia ʻo GAVRETO, ʻaʻohe hōʻailona palekana hou i ʻike ʻia. Ua hōʻike ʻia nā hopena no ka hui hoʻopaʻa inoa inoa ʻana o Kina i ka wā o ka wā o ka haʻihaʻi ʻana o ka waha abstract i ka 90th Annual Meeting of the American Thyroid Association (ATA) 2021.

He aha e lawe ʻia mai kēia ʻatikala:

The approval expanded the labeled indications of GAVRETO in China to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who requires systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive TC who requires systemic therapy and radioactive iodine-refractory (if radioactive iodine treatment is appropriate).
As of a data cutoff date of April 12, 2021, a total of 28 patients with advanced RET-mutant MTC were enrolled in the China MTC registrational bridging cohort of the global ARROW study, and received a starting GAVRETO dose of 400mg once daily.
The sNDA approval is based on results from the global phase 1/2 ARROW trial, designed to evaluate the safety, tolerability and efficacy of GAVRETO in patients with RET fusion-positive NSCLC, RET-mutant MTC, and other advanced solid tumors with RET fusions.