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ifinatamab deruxtecan

Daiichi Sankyo / Merck

Standard Review Phase 2 Breakthrough Therapy

PDUFA Date

May 30, 2026

Time Remaining

67 days

Review Type

Standard (10 mo)

Indication

Small cell lung cancer (SCLC) — B7-H3 ADC

Key Notes

IDeate-Lung01 Phase 2 trial data expected for presentation at ASCO 2026. Ifinatamab deruxtecan (I-DXd) is a B7-H3–targeted ADC with significant activity in SCLC, where treatment options remain limited.

⚠️ 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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