Sabuwar Aikace-aikacen Magunguna don Metastatic Triple-Negative Breast Cancer

Sakin Kyauta | eTurboNews | eTN
Written by Linda Hohnholz

Everest Medicines Limited, wani kamfani na biopharmaceutical da ke mayar da hankali kan haɓakawa da kasuwancin samfuran magunguna masu canzawa a Asiya, ya sanar a yau cewa Hukumar Abinci da Magunguna ta Taiwan (TFDA) ta karɓi ƙaddamar da Sabuwar Aikace-aikacen Magunguna (NDA) don sacituzumab govitecan (SG) a cikin manya marasa lafiya. tare da ci gaba na cikin gida ko na TNBC mai tsauri wanda ba a iya gano su ba waɗanda suka karɓi tsarin jiyya biyu ko fiye da suka gabata, aƙalla ɗaya daga cikinsu don cututtukan metastatic. An ba da maganin Jiyya na Yara da Rare Tsananin Nazari na Nazari na Farko ta FDA ta Taiwan a cikin Yuli 2021.

A ƙarƙashin sunan kasuwanci Trodelvy®, FDA ta Amurka a baya ta ba da izini ga SG a cikin Afrilu 2020 sannan ta faɗaɗa alamarta tare da cikakkiyar yarda a cikin Afrilu 2021 ga manya marasa lafiya waɗanda ba su da haɓaka a cikin gida ko mTNBC waɗanda suka karɓi tsarin warkewa biyu ko fiye da suka gabata, a aƙalla ɗaya daga cikinsu don cututtukan metastatic. A watan Mayun 2021, Everest ta ba da sanarwar cewa Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar Sin ta karɓi aikace-aikacen lasisin nazarin halittu tare da yin bitar fifiko ga SG ga manya marasa lafiya waɗanda ke da ci gaba a cikin gida ko kuma waɗanda ba su da ƙarfi na TNBC waɗanda suka karɓi magunguna biyu ko fiye da na gaba na tsarin, aƙalla ɗaya daga cikinsu don metastatic. cuta.

A cikin Nuwamba 2021, Everest ta ba da sanarwar babban sakamako don karatunta na Mataki na 2b EVER-132-001 na SG, wanda ya hadu da ƙarshen ƙarshen sa tare da ƙimar amsa gabaɗaya 38.8% (ORR). Wannan binciken ya hada da mutane 80 a kasar Sin, kuma sakamakon ya yi daidai da wadanda suka fito daga binciken ASCENT na Phase 3 na duniya, don haka ya nuna irin wannan inganci a cikin jama'ar kasar Sin. 

TNBC ita ce nau'in ciwon nono mafi tsanani kuma yana da kimanin kashi 15% na dukan ciwon nono. Matsakaicin shekarun gano cutar sankarar nono yana nuna ƙarami a cikin Asiya fiye da ƙasashen yamma, kuma adadin ƙwayar ƙwayar cuta ta TNBC yana ƙaruwa a cikin shekaru 10 da suka gabata. Kwayoyin TNBC ba su da isrogen da masu karɓa na progesterone kuma suna da iyakacin ƙimar haɓakar haɓakar haɓakar ɗan adam 2 (HER2). Saboda yanayin TNBC, zaɓuɓɓukan magani masu inganci suna da iyaka sosai idan aka kwatanta da sauran nau'in ciwon nono. TNBC yana da mafi girman damar sake dawowa da metastases fiye da sauran nau'in ciwon nono. Matsakaicin lokacin dawowar metastatic na TNBC kusan shekaru 2.6 ne idan aka kwatanta da shekaru 5 na sauran cututtukan nono, kuma adadin tsira na shekaru biyar ya ragu sosai. Daga cikin matan da ke da TNBC mai tsauri, adadin rayuwa na shekaru biyar shine 12%, idan aka kwatanta da 28% ga waɗanda ke da wasu nau'ikan ciwon nono na metastatic.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

  • A watan Mayun 2021, Everest ta ba da sanarwar cewa Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar Sin ta karɓi aikace-aikacen lasisin nazarin halittu tare da yin bitar fifiko ga SG ga manya marasa lafiya waɗanda ke da ci gaba a cikin gida ko kuma waɗanda ba su da ƙarfi na TNBC waɗanda suka karɓi magunguna biyu ko fiye da na gaba na tsarin, aƙalla ɗaya daga cikinsu don metastatic. cuta.
  • FDA a baya ta ba da izini ga SG a cikin Afrilu 2020 sannan kuma ta faɗaɗa nuni tare da cikakkiyar yarda a cikin Afrilu 2021 don manya marasa lafiya waɗanda ba su da haɓaka a cikin gida ko mTNBC waɗanda suka karɓi magunguna biyu ko fiye da na gaba na tsarin, aƙalla ɗaya daga cikinsu don cututtukan metastatic.
  • Matsakaicin shekarun gano cutar sankarar nono yana nuna ƙarami a cikin Asiya fiye da ƙasashen yamma, kuma adadin ƙwayar ƙwayar cuta ta TNBC yana ƙaruwa a cikin shekaru 10 da suka gabata.

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Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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