AnHeart Therapeutics and NewG Lab Pharma subsidiary NewG Lab Therapeutics have received orphan drug designation in Korea for the next-generation tyrosine kinase inhibitor (TKI), taletrectinib, to treat advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The Ministry of Food and Drug Safety (MFDS) in Republic of Korea granted the designation to taletrectinib to treat NSCLC)in adult patients.
Taletrectinib has been designed for effectively targeting ROS1 fusions to treat TKI-naïve and pre-treated patients.
AnHeart Therapeutics CEO Junyuan (Jerry) Wang said: “There is a high unmet need for this specific patient population in lung cancer, where very few treatment options are available.
“We look forward to working with the regulatory agency in Republic of Korea, to accelerate the development of taletrectinib for patients in Korea.”
The international phase II (TRUST-II) clinical trial is currently being conducted at several locations in Korea that include Chonnam National University Hospital in Hwasun and Asan Medical Center in Seoul.
Last month, the therapy received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) to treat advanced or metastatic ROS1-positive NSCLC adult patients who are ROS1 TKI treatment naïve or received crizotinib earlier.
The regulatory decision was supported by the preliminary clinical data obtained from an ongoing Phase II TRUST clinical trial in ROS1-positive NSCLC patients in China, and two completed Phase I trials that were conducted in the US and Japan.
AnHeart out-licensed taletrectinib’s clinical development and commercialisation rights to NewG Lab in the Republic of Korea, in July 2020.
Under the deal, NewG Lab agreed to develop and commercialise taletrectinib in the country.