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Enhertu + Perjeta (fam-trastuzumab deruxtecan-nxki + pertuzumab)

AstraZeneca / Roche · $AZN

Priority Review Breakthrough Therapy sBLA

PDUFA Date

January 20, 2026

Time Remaining

63d ago

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical sBLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

First-line HER2-positive metastatic breast cancer (combination)

Key Notes

Supplemental BLA for Enhertu + pertuzumab combination in HER2+ metastatic breast cancer.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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