Hanmi and Boehringer's olmutinib gains first approval, in South Korea

Olmutinib (BI 1482694/HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

The approval represents a first for regulatory authorities in South Korea and is a major breakthrough for patients. The compound will be distributed in South Korea by Hanmi Pharmaceutical under the name olmutinib, according to German family-owned pharma major Boehringer Ingelheim, which is partnering on the development of this drug.

This approval is based on the results of the Phase I/II HM-EMSI-101 [NCT01588145] clinical trial which showed promising clinical activity for olmutinib (BI 1482694 / HM61713):