[Yonhap News Photo]
South Korea's food and drug safety watchdog approved the sale of a new cancer therapy called "Olmutinib" at home Tuesday only after patients agreed to get it and were fully informed of its side effects.
The Ministry of Food and Drug Safety said it would maintain an earlier decision to approve the sale of Olmutinib known as HM61713 or BI148294, produced by Hanmi Pharmaceutical Co.
The ministry, however, stressed that doctors should receive consent form from patients before using the drug, in order to provide a treatment opportunity for patients who have no alternative treatment.
Olmutinib has been touted as a "breakthrough therapy" by the US Food and Drug Administration for patients who have developed a tolerance to existing lung cancer treatments.
The drug was conditionally approved for sale in South Korea in May, and Hanmi had tried to commercialize it under an exclusive partnership agreement with German pharma giant Boehringer Ingelheim which had carried out clinical trials in Europe.
However, Hanmi's plan was put on hold after a patient died of a severe skin-related side effect. Last week Boehringer Ingelheim ended its licensing deal with Hanmi and South Korean regulators prohibited doctors from prescribing Olmutinib, citing three cases of life-threatening side effects during clinical trials.
Of 730 patients treated with Olmutinib, two showed symptoms of toxic epidermal necrolysis and one died during Boehringer Ingelheim's clinical trials abroad.
Aju News Lim Chang-won = cwlim34@ajunews.com
reporter
Park Sae-jin
swatchsjp@ajunews.com
