PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC)
Key Notes
ODAC (Oncologic Drugs Advisory Committee) meeting April 30, 2026 — AFTERNOON SESSION. Committee will review sNDA 218197/S-004 for Truqap (capivasertib) in combination with abiraterone acetate (Zytiga) for PTEN-deficient de novo mHSPC. CAPItello-281 Phase 3 met primary rPFS endpoint (33.2 vs 25.7 months; HR 0.81; p=0.034). First AKT inhibitor sNDA for prostate cancer. Truqap is already approved for HR+ breast cancer. PDUFA estimated June-July 2026.
⚠️ 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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