Shots:
- The CHMP’s positive opinion was based on the P-III (CAPItello-291) study assessing Truqap + Faslodex vs PBO + Faslodex to treat ER+, HER2‑ locally advanced or metastatic breast cancer patients (n=708) having ≥1 PIK3CA, AKT1 or PTEN-alterations after recurrence or progression on or after an endocrine-based regimen
- The study demonstrated reduction in the disease progression & death risk by 50% in patients having PI3K, AKT or PTEN alterations with mPFS of 7.3mos. vs 3.1mos. The data was published in The New England Journal of Medicine
- Regulatory applications are under review across China & other countries. Based on P-III results, combination for same indication has been approved in the US, Japan & other countries
Ref: AstraZeneca | Image: AstraZeneca| Press Release
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