I lalo o le igoa tau fefaʻatauaʻiga Trodelvy®, na tuʻuina atu muamua e le US FDA le faʻatagaina vave i le SG ia Aperila 2020 ona faʻalauteleina lea o lona faʻamaoniga ma le faʻatagaina atoatoa ia Aperila 2021 mo tagata matutua e le mafai ona faʻaogaina i le lotoifale poʻo le mTNBC oe na mauaina muamua le lua pe sili atu togafitiga faʻapitoa, i le le itiiti ifo ma le tasi o latou mo faʻamaʻi metastatic. I le masina o Me 2021, na faʻasalalau ai e Everest e talia e le China National Medical Products Administration lana Talosaga Laisene Biologics ma le faʻamuamua iloiloga mo SG mo tagata matutua maʻi e le mafai ona faʻaogaina i le lotoifale poʻo le metastatic TNBC oe na mauaina muamua le lua pe sili atu togafitiga faʻapitoa, a itiiti ifo ma le tasi o latou mo metastatic. faama'i.

Ia Novema 2021, na faʻasalalau ai e Everest faʻaiʻuga pito i luga mo lana Vaega 2b EVER-132-001 suʻesuʻega o le SG, lea na ausia lona faʻaiʻuga muamua ma le 38.8% le aofaʻi o tali (ORR). O lenei suʻesuʻega na aofia ai le 80 tagata i Saina, ma o faʻaiʻuga na ogatasi ma i latou mai le lalolagi Phase 3 ASCENT suʻesuʻega, ma faʻaalia ai le aoga tutusa i le faitau aofaʻi o Saina.

O le TNBC o le ituaiga sili ona malosi o le kanesa o le susu ma e tusa ma le 15% o kanesa uma o susu. Ole vaeluaga ole tausaga ole su'esu'ega ole kanesa o le susu e foliga mai e la'ititi i Asia nai lo atunu'u i sisifo, ma o le pasene ole TNBC molecular subtype ua fa'atupula'ia ile 10 tausaga talu ai. O sela TNBC e leai ni mea e maua ai le estrogen ma le progesterone ma e faʻatapulaʻaina le tagata epidermal growth factor receptor 2 (HER2). Ona o le natura o le TNBC, e matua fa'atapula'a filifiliga togafitiga lelei pe a fa'atusatusa i isi ituaiga o kanesa o le susu. O le TNBC e maualuga atu le avanoa e toe fo'i mai ai ma fa'ama'i pipisi nai lo isi ituaiga o kanesa o le susu. O le averesi o le taimi e toe fo'i mai ai le metastatic mo le TNBC e tusa ma le 2.6 tausaga fa'atusatusa i le 5 tausaga mo isi kanesa o le susu, ma o le fua faatatau o le ola e lima tausaga e sili atu ona maualalo. I fafine e maua i le metastatic TNBC, o le lima tausaga e ola ai e 12%, fa'atusatusa i le 28% mo i latou e maua i isi ituaiga o kanesa o le susu metastatic.

OA MEA E AVEA MAI LENEI TUSI:

In May 2021, Everest announced that the China National Medical Products Administration accepted its Biologics License Application with priority review for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
FDA previously granted accelerated approval to SG in April 2020 and then expanded its indication with full approval in April 2021 for adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years.