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.

"Boehringer Ingelheim is pleased that the FDA has granted Breakthrough Therapy designation to our investigational third-generation EGFR inhibitor BI 1482694. We feel this designation reflects the potential of the compound to be an important part of the treatment of non-small cell lung cancer in patients with T790M mutation," said Tarek Sahmoud, vice president, oncology clinical development and medical affairs, adding: "The continued development of BI 1482694 and our entire oncology portfolio underscores our commitment to advancing novel treatment approaches designed to help improve the lives of people with cancer."