[Courtesy of Hanmi]
SEOUL -- South Korea's leading drug maker Hanmi Pharmaceutical has put an end to the development of its first new cancer therapy called "Olita (Olmutinib)", citing the global use of a rival drug produced by AstraZeneca, an Anglo–Swedish pharmaceutical company.
Olita used to be touted as a "breakthrough therapy" for patients who have developed a tolerance to existing lung cancer treatments. It received conditional approval from the Ministry of Food and Drug Safety in 2016.
Hanmi once tried to commercialize Olita under a partnership agreement with German partner Boehringer Ingelheim, but the German partner walked away, citing cases of side effects during clinical trials.
The food and drug watchdog said Friday that it has received Hanmi's decision to stop Olita's development and sale because it was not able to recruit patients for mandatory "phase 3" clinical trials.
Hanmi said Olita has lost its competitiveness as a "breakthrough" therapy because AstraZeneca's Tagrisso was already covered by health insurance and used in many countries. Tagrisso has been granted "breakthrough therapy designation" by the US Food and Drug Administration as the first-line treatment of patients with metastatic non-small cell lung cancer.
reporter
Lim Chang-won
cwlim34@ajunews.com
