Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. Faslodex alone in a biomarker-altered population
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
Application based on results from the TROPION-Breast01 Phase III trial
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations
The surgeons were able to remove the entire breast while preserving the nipple through tiny hidden incisions
This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients
Subgroup analysis by HER2 expression from phase 1/2 trial of patients with HER3 expressing metastatic breast cancer highlighted in a second Presidential Session
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