Breaking News, Trials & Filings

FDA Grants Priority Review to Boehringer Ingelheim’s NDA for Zongertinib

Zongertinib is being developed for HER2 (ERRB2)-mutant advanced non-small cell lung cancer (NSCLC).

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Priority Review to Boehringer Ingelheim’s new drug application for zongertinib (BI 1810631) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy. The FDA grants Priority Review to applications for drugs that would offer significant improvements in the treatment, diagnosis, or prevention of serious condit...

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