Shots:
- FDA has approved AZ‘s Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU
- Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone & ADT in 1,012 adults with newly diagnosed PTEN-deficient mAPMN/S prostate cancer
- Primary analysis of the trial showed a 19% reduction in the risk of radiographic disease progression or death (1EP), with a median rPFS of 33.2 vs 25.7mos. OS (2EP) data were immature, but favored Truqap combination & is under assessment; data published in Annals of Oncology
Ref: Businesswire | Image: AstraZeneca | Press Release
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