HUTCHMED Ta Sanar Da Amincewa Da Sharaɗin NMPA Ga TAZVERIK® (tazemetostat) Don Maganin Ciwon Lymphoma Mai Lalacewa Ko Mai Juya Baya.

A ranar 21 ga Maris, 2025, ta sanar da cewa an ba da izinin amfani da Sabon Magani ("NDA") don TAZVERIK® (tazemetostat) a China don maganin manya marasa lafiya da suka sake komawa baya ko kuma suka sake yin rashin lafiya ("R/R") follicular lymphoma ("FL") tare da maye gurbin EZH2 waɗanda suka sami aƙalla magunguna biyu a baya. Wannan amincewa ta biyo bayan matsayin sake duba fifiko na Hukumar Kayayyakin Lafiya ta Ƙasa ("NMPA") kuma ta zama amincewar farko ta ƙa'idoji a duk faɗin ƙasar don TAZVERIK® a China.

An sami goyon bayan amincewa da sharaɗi daga NMPA ta hanyar sakamako daga wani bincike mai cike da cibiyoyi da yawa, wanda aka buɗe a China, da kuma nazarin asibiti da Epizyme, Inc. (“Epizyme”), wani kamfanin Ipsen, ya gudanar a wajen China. Babban manufar binciken gadoji shine a kimanta ƙimar amsawar da aka yi da gangan (“ORR”) na TAZVERIK® don maganin marasa lafiya da ke fama da R/R FL waɗanda cutar ta haifar da maye gurbi na EZH2. Manufofin biyu sun haɗa da tsawon lokacin amsawa (“DoR”), rayuwa ba tare da ci gaba ba (PFS), da kuma rayuwa gabaɗaya (OS) na TAZVERIK® don maganin marasa lafiya da ke fama da R/R FL, da kuma kimanta aminci da pharmacokinetics. Ana iya samun ƙarin bayani a clinicaltrials.gov, ta amfani da mai ganowa.NCT05467943.

TAZVERIK® wani maganin hana methyltransferase ne na farko a cikin aji na EZH2 wanda Epizyme ya haɓaka. Hukumar Abinci da Magunguna ta Amurka ("FDA") ta amince da shi don maganin wasu marasa lafiya da ke fama da R/R FL da wasu marasa lafiya da ke fama da sarcoma na epithelioid ("ES") a ƙarƙashin shirin amincewa da sauri na FDA. Ma'aikatar Lafiya, Ma'aikata da Jin Daɗi ta Japan (MHLW) ta kuma amince da shi ga wasu marasa lafiya da ke fama da R/R FL.

Tazemetostat magani ne mai hana methyltransferase wanda aka nuna a Amurka don magance:

Manya da yara 'yan shekara 16 zuwa sama da suka kamu da cutar kansa ko kuma waɗanda suka kamu da cutar a yankinsu ba su cancanci a yi musu tiyatar cirewa gaba ɗaya ba.

Manya marasa lafiya da ke fama da R/R FL waɗanda ciwonsu ya tabbata cewa suna da canjin EZH2 kamar yadda aka gano ta hanyar gwajin da FDA ta amince da shi, kuma waɗanda suka sami aƙalla magunguna biyu na yau da kullun.

Manya marasa lafiya da ke fama da R/R FL waɗanda ba su da wasu hanyoyin magani masu gamsarwa.

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

和黄医药 (hutch-med.com)