Pralsetinib

Phase 3

Roche Holding AG (RHHBY)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in RET-fusion Non Small Cell Lung Cancer

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Drug Information

Target Indication

RET-fusion Non Small Cell Lung Cancer

Clinical Trial

NCT04222972

Last updated: 2/9/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA11/18/2021

Gavreto

Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Conditional

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Drug Science

Mechanism of action & safety profile

Developer

RHHBY

Roche Holding AG

Biotechnology•Europe•NYSE

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