Ngwa ọgwụ ọhụrụ maka ọgwụgwọ ọrịa kansa thyroid

CStone Pharmaceuticals taa mara ọkwa na National Medical Products Administration (NMPA) nke China akwadola ngwa mgbakwunye ọhụrụ ọgwụ (sNDA) nke nhọrọ RET inhibitor GAVRETO® (pralsetinib) maka ọgwụgwọ nke ọrịa cancer thyroid medullary (MTC) na RET fusion. - ọrịa cancer thyroid dị mma (TC). Nkwenye ahụ gbasaa akara ngosi nke GAVRETO na China gụnyere ndị okenye na ndị ọrịa ụmụaka dị afọ 12 na ndị okenye nwere ọganihu ma ọ bụ metastatic RET-mutant MTC nke na-achọ ọgwụgwọ usoro, na ndị okenye na ụmụaka ndị dị afọ 12 na ndị okenye nwere ọganihu ma ọ bụ metastatic. RET fusion-positive TC onye chọrọ usoro ọgwụgwọ na redioaktivu iodine-refractory (ọ bụrụ na ọgwụgwọ redioaktivu redio kwesịrị ekwesị).

Achọpụtara ya site n'aka onye mmekọ CSstone Blueprint Medicines, GAVRETO bụ ihe mgbochi RET nwere ike ma họrọ. CSstone nwere mmekorita ya na nkwekọrịta ikike ya na Blueprint Medicines maka mmepe na ahia nke GAVRETO na Greater China, nke gunyere Mainland China, Hong Kong, Macau na Taiwan.

Dr. Frank Jiang, Onye isi oche na CEO nke CSstone, kwuru, sị, "Anyị nwere nnọọ obi ụtọ maka nkwado sNDA nke GAVRETO, nke ga-enye nhọrọ ọgwụgwọ ọhụrụ maka ndị ọrịa China nwere ọrịa cancer RET-mutant medullary thyroid dị elu na RET fusion-positive thyroid cancer. . Anyị chọkwara ịgbatị ekele pụrụ iche nye NMPA maka ntụle mbụ. CSstone na-agba mbọ mgbe niile n'ịmepụta usoro ọgwụgwọ ọhụrụ iji gboo mkpa ahụike na-egbobeghị nke ndị ọrịa kansa. Anyị ga-aga n'ihu n'ịkwalite uru ụlọ ọgwụ na ikike nke pipeline anyị, ma gbasie mbọ ike inye ndị ọrịa n'ụwa niile ọgwụ dị oke mma, nke ọhụrụ."

Prọfesọ Ming Gao, onye isi nyocha nke ọmụmụ ARROW na Onye isi oche nke Tianjin Union Medical Center, kwuru, “Ọnụ ọgụgụ nke ọrịa kansa thyroid na-arị elu n'afọ ndị na-adịbeghị anya. Enwere nhọrọ ọgwụgwọ nwere oke na ụlọ ọgwụ maka ọgwụgwọ MTC, yana enwere mkpa ngwa ngwa maka ọgwụgwọ nkenke, ọkachasị maka ndị ọrịa nwere RET-mutant MTC. GAVRETO gosipụtara ọrụ mgbochi tumor siri ike ma na-adịgide adịgide n'ime ndị ọrịa China nwere RET-mutant MTC dị elu ma ọ bụ metastatic, yana nchekwa zuru oke kwekọrọ na nsonaazụ a hụrụ na ọmụmụ ARROW zuru ụwa ọnụ. Site na mgbasawanye nke akara ngosi GAVRETO, anyị na-atụ anya ilebara mkpa ahụike nke ndị ọrịa thyroid ọrịa na-adịghị mma.

Dr. Jason Yang, onye isi nlekọta ahụike nke CSstone, kwuru, sị, "Nkwenye NMPA nke sNDA bụ isi ihe ọzọ dị mkpa nye anyị mgbe a kwadoro GAVRETO maka ọgwụgwọ ndị ọrịa nwere mpaghara ma ọ bụ metastatic RET fusion-positive na-abụghị obere cell cancer cancer. . Ọ ga-amasị anyị ikele ndị ọrịa na ndị nyocha niile nyere aka na nyocha ụlọ ọgwụ nke GAVRETO na ngosipụta gbasaara. Anyị ga-aga n'ihu na-aga n'ihu nyocha ụlọ ọgwụ nke GAVRETO maka ọgwụgwọ nke ụdị ọrịa cancer dị iche iche ka anyị wee nwee ike weta ọgwụgwọ ọhụrụ a ngwa ngwa iji nyere aka rite uru karịa ndị ọrịa.

Nkwenye sNDA dabere na nsonaazụ sitere na usoro ikpe 1/2 ARROW zuru ụwa ọnụ, emebere iji nyochaa nchekwa, nnabata na arụmọrụ nke GAVRETO na ndị ọrịa nwere RET fusion-positive NSCLC, RET-mutant MTC, na etuto siri ike ndị ọzọ nwere RET fusions. . Dịka ụbọchị nbibi data nke Eprel 12, 2021, ngụkọta nke ndị ọrịa 28 nwere RET-mutant MTC toro eto ka edebanyere aha na China MTC ndebanye aha nke ọmụmụ ARROW zuru ụwa ọnụ, wee nata usoro GAVRETO mmalite nke 400mg otu ugboro kwa ụbọchị. Nsonaazụ ọmụmụ ahụ gosiri na ọnụego nzaghachi ebumnobi ekwenyesiri ike (ORR) nke ndị ọrịa 26 RET-mutant MTC nwere ọrịa a na-enyocha na ntọala bụ 73.1%, gụnyere 3 nwere nzaghachi zuru oke (CR) na 16 nwere nzaghachi akụkụ (PR). Ọnụọgụ nchịkwa ọrịa (DCR) bụ 84.6%, a na-ahụkwa nzaghachi n'agbanyeghị ụdị mmụgharị RET. N'ime ndị ọrịa 19 nwere nzaghachi ekwenyesiri ike, oge nzaghachi nke etiti (DOR) eruteghị, na ọnụọgụ DOR nke ọnwa 9 bụ 100%. Calcitonin na carcinoembryonic antigen (CEA) belatara nke ukwuu. A na-anabatakarị GAVRETO nke ọma, na-enweghị akara nchekwa ọhụrụ ahụrụ. Nsonaazụ maka ndị otu ndebanye aha China ka ewepụtara n'oge nnọkọ okwu ọnụ na-emebi ngwụcha na Nzukọ Kwa Afọ 90 nke American Thyroid Association (ATA) 2021.