Breakthrough Therapy designation for Boehringer's BI 1482694
The US Food and Drug Administration has granted Breakthrough Therapy Designation to German family-owned pharma major Boehringer Ingelheim’s investigational third-generation epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713).
The designation is based on results from the Phase I/II HM-EMSI-101 clinical trial evaluating the treatment of T790M mutation-positive non-small cell lung cancer (NSCLC) in patients whose tumors have stopped responding to currently available EGFR-directed therapies.
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