FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate
News Jan 06, 2016
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.
y conjuring the spell “Lumos!” wizards in the mythical world of Harry Potter could light up the tip of their magic wands and illuminate their surroundings. So, too, does LumosVar, a computer program that “lights up” cancer-causing genetic Var-ients, or mutations, illuminating how physicians might best treat their patients.READ MORE