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Korean Authorities Mull New Steps, Probe Over Olmutinib Events

 
• By Jung Won Shin

Additional safety measures including a possible sales suspension are to be discussed by a review committee in South Korea on Oct. 4 that will help decide the fate of Hanmi’s EGFR inhibitor olmutinib. Financial authorities in the country are also launching a probe into the timing of the disclosure of several cases of serious adverse events with the drug.

Drugs question mark

South Korea’s Ministry of Food and Drug Safety (MFDS) has distributed safety letters to inform domestic medical professionals, patients and consumer groups about the occurrence of serious adverse skin reactions during clinical trials with Hanmi Pharmaceutical Co. Ltd.'s cancer drug olmutinib, which was launched for the first time globally in the country earlier this year.

The adverse reactions include one case of Stevens Johnson syndrome (SJS) and two cases of toxic epidermal necrolysis (TEN) and...

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