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EMA Product

Gavreto

Product approved by European Medicines Agency (EU)

Basic Information

Gavreto

Regulatory Information

EMEA/H/C/005413

Withdrawn

November 18, 2021

September 16, 2021

8

July 22, 2024

Company Information

Netherlands

Gustav Mahlerplein 2 1082MA Amsterdam

Blueprint Medicines (Netherlands) BV

Drug Classification

Conditional Approval

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication 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.

Overview Summary

Gavreto is a cancer medicine for treating adults with advanced non-small cell lung cancer caused by changes in a gene called RET (known as RET fusion-positive NSCLC) and who have not been treated with a RET inhibitor. Gavreto contains the active substance pralsetinib.

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