German pharmaceutical firm Boehringer Ingelheim has received approval for olmutinib (BI 1482694 / HM61713) in South Korea, to treat patients suffering from locally advanced or metastatic, epidermal growth factor receptor (EGFR), T790M, mutation-positive, non-small cell lung cancer (NSCLC).
The treatment can work on patients who had previously been treated with an EGFR tyrosine kinase inhibitor (TKI).
Hanmi Pharmaceutical will be responsible for distributing the compound in South Korea, under the name olmutinib.
The South Korean approval is based on the successful results of the Phase I/II HM-EMSI-101 (NCT01588145) clinical trial.
Sungkyunkwan University School of Medicine Seoul South Korea Samsung Medical Centre innovative cancer medicine institute (ICMI) director Keunchil Park said: "The approval of olmutinib is a great step forward for lung cancer patients in South Korea.
"This is an exciting and much needed new treatment option for the majority of EGFR mutation-positive lung cancer patients whose disease has become resistant to first-line TKI therapy, which can be a devastating development."
Olmutinib (BI 1482694 / HM61713) is a third-generation, oral, EGFR mutation-specific TKI.
The primary Phase II trial ELUXA 1 (HM-EMSI-202 [NCT02485652]) is under way, thereby enrolling EGFR T790M, mutation-positive lung cancer patients who have become resistant to TKI treatment for the olmutinib treatment.
Last year, Boehringer signed an exclusive license agreement with Hanmi to gain exclusive rights for the product across the globe, except in South Korea and Hong Kong.
ZAI Lab has secured exclusive rights for the product within China, including Hong Kong and Macau.
Image: Micrographs of positive non-small cell lung cancer. Photo: courtesy of Nephron / Wikipedia.