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AstraZeneca Reports the US FDA Acceptance of NDA and Granted Priority Review of Capivasertib + Faslodex (fulvestrant) for Advanced HR-Positive Breast Cancer

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AstraZeneca Reports the US FDA Acceptance of NDA and Granted Priority Review of Capivasertib + Faslodex (fulvestrant) for Advanced HR-Positive Breast Cancer

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  • The US FDA has accepted the NDA & granted Priority Review for capivasertib + fulvestrant in adult patients with HR+ HER2- LA or metastatic breast cancer. The US FDA’s decision is expected in Q4’23
  • The NDA was based on the P-III trial (CAPItello-291) results presented at SABCS 2022 & published in the NEJM evaluating capivasertib + Faslodex vs PBO + Faslodex in 708 adult patients, showed a 40% reduction in risk of disease progression or death in the overall trial population; m-PFS (7.2 vs 3.6mos.), OS data were immature, early data are encouraging & the safety profile was similar to prior reported trials
  • Capivasertib was discovered by AstraZeneca in collaboration with Astex Therapeutics (and its collaboration with ICR & CRT). The company works with the US FDA to bring the therapy to patients shortly

Ref: AstraZeneca Image: AstraZeneca

Related News:- AstraZeneca Presents P-III Trial (CAPItello-291) of Faslodex (fulvestrant) + Capivasertib for Advanced HR-Positive Breast Cancer at SABCS 2022

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