April 24, 2024

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[THE INVESTOR] South Korea’s state audit agency is poised to scrutinize a controversial lung cancer treatment developed by the drug maker Hanmi Pharmaceutical, following a parliamentary audit that sparked concerns on side effects. 

The National Assembly’s Health and Welfare Committee on Nov. 7 voted to request a special probe by the Board of Audit and Inspection on the death of patient linked to the drug’s use and the decision by the country’s health authorities to retain sales approval for Olmutinib.

The move came after the Ministry of Food and Drug Safety revised up the number of patients who were found to have suffered from skin-related side effects after partaking in the drug’s clinical trials from three to five, including one death, during a parliamentary audit on Oct. 14.

“There was one patient who died from a direct adverse drug reactions related to Olmutinib. Other four patients also had adverse reactions to the drug but they died from other illness,” said Sohn Mun-gi, minister of food and drug safety during the inspection.

Hanmi’s lung cancer drug Olmutinib, also known as HM61713 or BI148294, is a third-generation lung cancer therapy for patients who have developed a tolerance to existing lung cancer treatments.

Olmutinib was conditionally approved for sale in Korea in May under the name “Olita Tab.” after completing just first and second phase trials held locally.

On Oct. 4, the MFDS said it would maintain its earlier decision to approve the sale of the drug, following German pharmaceutical giant Boehringer Ingelheim’s announcement that it would end a license deal with Hanmi over the cancer treatment after one patient died during the Phase 2 clinical trials.

By Park Han-na (hnpark@heraldcorp.com)