AstraZeneca Received the US FDA's Approval for Truqap (capivasertib) + Fulvestrant to Treat the Patient with Advanced HR-Positive Breast Cancer
- The approval was based on P-III (CAPItello-291) study evaluating efficacy of Truqap (400mg; BID) + fulvestrant vs PBO + fulvestrant on breast cancer patients (n=708). The Dual 1EP of the study was PFS on the overall population & on patients whose tumors have qualifying alterations in the PI3K/AKT/PTEN gene
- The result showed 50% reduction in death vs fulvestrant alone in patients with furthermore median PFS was 7.3 vs 3.1mos. The safety profile was consistent with previous data. The result was published in NEJM
- The US FDA granted Priority Review examined by Project Orbis under which Truqap + fulvestrant is under review by other regulatory authorities
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