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30-09-2021 | EMA | News

approvalsWatch

Pralsetinib receives nod from EMA for use in RET-positive NSCLC

Author:
Hannah Kitt

medwireNews: The EMA has recommended granting a conditional marketing authorization to pralsetinib for use in patients with RET fusion-positive non-small-cell lung cancer (NSCLC) who are RET inhibitor-naïve.

This decision by the EMA’s Committee for Medicinal Products for Human Use follows positive findings of the RET receptor tyrosine kinase inhibitor (previously known as BLU-667) in this patient population in the pivotal phase 1/2 ARROW study.

Pralsetinib will be available as 100 mg hard capsules.

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