Shots:
- The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU
- sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC
- Trial showed a 52% reduction in the risk of radiographic progression or death, with consistent benefit across pts with BRCA & non-BRCA HRR gene alterations; data were presented at ASCO’26 & published in The NEJM
Ref: Businesswire | Image: Pfizer | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us atconnect@pharmashots.com
