Sou non komèsyal Trodelvy®, FDA Etazini te deja akòde apwobasyon akselere bay SG nan mwa avril 2020 epi answit te elaji endikasyon li a ak apwobasyon total an avril 2021 pou pasyan adilt ki pa resektabl lokalman avanse oswa mTNBC ki te resevwa de oswa plis terapi sistemik anvan, nan omwen youn nan yo pou maladi metastatik. Nan mwa me 2021, Everest te anonse ke China National Medical Products Administration te aksepte aplikasyon pou lisans byolojik li yo ak revizyon priyorite pou SG pou pasyan adilt ki gen TNBC ki pa resektabl lokalman avanse oswa metastatik ki te resevwa de oswa plis terapi sistemik anvan, omwen youn nan yo pou metastatik. maladi.

Nan mwa novanm 2021, Everest te anonse rezilta prensipal yo pou etid Faz 2b EVER-132-001 li sou SG, ki te rankontre pwen final prensipal li ak yon pousantaj repons jeneral (ORR) 38.8%. Etid sa a te gen ladann 80 moun nan peyi Lachin, ak rezilta yo te konsistan ak sa yo ki soti nan etid mondyal la Faz 3 ASCENT, konsa ki montre efikasite menm jan an nan popilasyon an Chinwa.

TNBC se kalite kansè nan tete ki pi agresif epi li reprezante apeprè 15% nan tout kansè nan tete. Laj medyàn nan dyagnostik kansè nan tete gen tandans pi piti nan peyi Azyatik pase peyi lwès yo, ak pousantaj la nan subtip molekilè TNBC te ogmante nan 10 ane ki sot pase yo. Selil TNBC yo pa gen reseptè estwojèn ak pwojestewòn epi yo gen limite faktè kwasans epidèm imen reseptè 2 (HER2). Akòz nati TNBC, opsyon tretman efikas yo trè limite konpare ak lòt kalite kansè nan tete. TNBC gen yon pi gwo chans pou yo repete ak metastaz pase lòt kalite kansè nan tete. Tan an mwayèn nan metastatik repetisyon pou TNBC se apeprè 2.6 ane konpare ak 5 ane pou lòt kansè nan tete, ak pousantaj siviv relatif senk ane a pi ba anpil. Pami fanm ki gen metastatik TNBC, pousantaj siviv senk ane a se 12%, konpare ak 28% pou moun ki gen lòt kalite kansè nan tete metastatik.

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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.