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First Approval Bodes Well For Hanmi's Olmutinib

 
• By Jung Won Shin

Hanmi’s novel lung cancer drug olmutinib is set to debut on the South Korean market later this year following its first approval globally after a fast-track review. The therapy will gain a domestic head start over AstraZeneca’s Tagrisso and international licensing deals have already been reached with Boehringer Ingelheim and ZAI Lab.

X-ray lung cancer
Lung cancer X-ray • Source: Shutterstock

Hanmi Pharmaceutical Co. Ltd.’s novel third-generation epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), olmutinib, has received an approval for lung cancer from South Korea’s Ministry of Food and Drug Safety (MFDS), paving the way for the drug to debut in this market ahead of its main competitor Tagrisso.

Hanmi expects to roll out the oral drug as Olita later this year, when it will become the first TKI therapy approved in the country for EGFR T790M mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC)

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