The South Korean Ministry of Food and Drug Safety said Tuesday that it has decided to uphold its conditional sales approval of Hanmi Pharmaceutical’s novel lung cancer therapy Olmutinib, which is suspected to have caused the death of one patient during clinical trials overseas.
Under the decision made by the ministry’s Central Pharmaceutical Affairs Council, doctors can prescribe Olmutinib, sold under the trade name “Olita Tab.” to local patients on the condition that they are thoroughly informed about the drug’s potential side effects and give their consent.
Kim Yeol-hong (right), chairman and board director of the Korean Cancer Association, briefs reporters about the Drug Ministry’s decision to conditionally allow the use of Hanmi’s novel lung cancer drug “Olita Tab.,” also known as Olmutinib, at the ministry’s Seoul office on Tuesday. (Yonhap)
“Though Olita Tab. was found to have caused severe skin-related side effects, we decided that the drug’s benefits outweigh the dangers of using the drug among patients who no longer respond to existing treatments,” the ministry said in a statement.
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 clinical trials held locally. The approval allowed Hanmi to start selling the drug on conditions that it submits its third phase clinical trials data at a later date.
Hanmi had also sold the drug’s global development and commercialization rights to Boeringer Ingelheim in a licensing partnership valued at $730 million back in July 2015.
However, the German drugmaker officially terminated its licensing deal last Friday, saying its decision was “based on a re-evaluation of all available clinical data on Olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer.”
The same day, the Korean Drug Ministry added new conditions on the drug’s use, citing three cases of serious skin-related side effects found among patients partaking in the drug’s clinical trials. The ministry prohibited doctors from prescribing Olmutinib to new patients and warned patients already using Olmutinib to “use the drug with caution” in consultation with doctors.
The ministry’s Tuesday decision overturned industry speculation that the sales of Olmutinib could be altogether banned in Korea.
Of 730 patients treated with Olmutinib, two patients showed symptoms of toxic epidermal necrolysis, while another patient was diagnosed with Stevens-Johnson syndrome, the ministry said.
Among the two patients diagnosed with TEN, one died due to the skin condition caused by using the drug, while another recovered. The patient diagnosed with SJS died due to the progression of the patient’s lung cancer.
The first death linked to TEN took place during Olmutinib’s second phase clinical trials abroad and was reported to the ministry in April. The two additional cases, which took place during second phase trials in Korea, were reported in June and September, respectively.
The ministry also issued an explanation as to why it had approved Hanmi’s Olmutinib for local sales in May when it had been notified by Hanmi in April that a patient had died after using the drug.
“The report submitted in April did not specify a causal link between using Olmutinib and the onset of TEN. The patient who died had been using another diabetes drug whose known side effects had included TEN,” the ministry said.
The drug regulator also noted that the June report also did not specify a causal link between use of Olmutinib and TEN and the patient recovered. The September report did not note a causal link between the use of Olmutinib and SJS as well, it said.
However, the ministry said it decided to issue a new safety warning on the use of the drug, given that there were now three reported cases of skin-related side effects among patients using Olmutinib.
To alleviate concerns over the safety of the drug, the ministry said it would closely monitor the health status of the patients prescribed with Olmtinib and to hold detailed sessions to educate doctors and patients about the risks of using Hanmi’s new lung cancer drug.
Hanmi Pharmaceutical said it will “sincerely follow the ministry’s newly-issued safety guidelines” in a statement to The Korea Herald.
Meanwhile, shares of Hanmi Pharmaceutical dropped by 7.3 percent on Tuesday, after the firm’s share price had plunged by more than 18 percent on the previous trading day on news that Boeringer Ingelheim had terminated its licensing partnership with Hanmi.
Korea’s financial authorities have also begun investigating whether Hanmi intentionally delayed its disclosure of the contract termination for possible insider trading, causing grave damages to investors.
By Sohn Ji-young (jys@heraldcorp.com)