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Korea To Limit Olmutinib Usage, Monitor All Patients

 
• By Jung Won Shin

After distributing safety letters on several cases of serious adverse skin reactions that occurred during the clinical development of Hanmi’s olmutinib, South Korean authorities have decided to limit the EGFR inhibitor to consenting patients and are closely monitoring its use.

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South Korea’s Ministry of Food and Drug Safety has decided to limit the usage of Hanmi Pharmaceutical Co. Ltd.'s EGFR inhibitor olmutinib only to patients who agree to use the drug after receiving thorough explanations from doctors on possible side effects including serious adverse skin reactions.

Olmutinib, which was approved in the country in May and launched for the first time globally in the country earlier this year, as Olita, is used in terminal non-small cell...

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