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FDA Grants Priority Review to Zongertinib for Treatment of HER2-Mutated, Advanced Non-Small Cell Lung Cancer

Summary by Pharmacy Times

Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.

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FDA Grants Priority Review to Zongertinib for Treatment of HER2-Mutated, Advanced Non-Small Cell Lung Cancer

Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.

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European Medical Journal

FDA fast-tracks Boehringer's NSCLC drug review

The FDA has granted Priority Review to Boehringer Ingelheim's new drug application for its non-small cell lung cancer therapy zongertinib.

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cancernetwork.com

Zongertinib Receives FDA Priority Review in HER2–Mutant Advanced NSCLC

Efficacy results from cohort 1 of the phase 1b Beamion LUNG-1 trial support the decision to review zongertinib in HER2-mutant advanced NSCLC.

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cancernetwork.com broke the news in 4 days ago on Wednesday, February 19, 2025.

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