FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate

Boehringer Ingelheim Pharmaceuticals has scored FDA breakthrough therapy designation for its candidate to treat patients with T790M mutation-positive non-small cell lung cancer.

BI 1482694 is a third-generation EGF mutant-specific tyrosine kinase inhibitor that has demonstrated strong anti-tumor activity and a favorable safety profile in patients whose tumors have stopped responding to currently available EGFR-directed therapies, according to the company.

The FDA awarded the designation based on results from Phase 1/2 clinical trial presented at the ESMO Asia 2015 Congress in Singapore.

Boehringer has an exclusive license and collaboration agreement with Hanmi Pharmaceutical for the development and commercial rights to BI 1482694, except in South Korea, China and Hong Kong.