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Lazcluze + Rybrevant (lazertinib + amivantamab-vmjw)

Johnson & Johnson · $JNJ

Priority Review Breakthrough Therapy sNDA

PDUFA Date

April 20, 2026

Time Remaining

27 days

Review Type

Priority (6 mo)

90%

Baseline PoA

Historical sNDA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

EGFR-mutated NSCLC — first-line treatment

Key Notes

First-line combination for EGFR-mutated non-small cell lung cancer. MARIPOSA trial data.

⚠️ 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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