Korean Ministry of Food and Drug Safety imposes conditions on the use of Olita Tab (olmutinib) for NSCLC.- Hanmi Pharmaceuticals.

South Korea�s Ministry of Food and Drug Safety (MFDS) has upheld its conditional approval of Olita Tab (olmutinib) (also known as HM61713 or BI148294) from Hanmi Pharmaceuticals despite the death of a patient during an overseas trial.The MFDS has imposed conditions on the drug�s use, citing three cases of serious skin-related side effects found among patients using the drug in clinical trials. The MFDS prohibited doctors from prescribing olmutinib to new patients and warned patients already using olmutinib to �use the drug with caution� in consultation with doctors.

Of 730 patients treated with olmutinib, two patients showed symptoms of toxic epidermal necrolysis (TEN), while another patient was diagnosed with Stevens-Johnson syndrome. 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 MFDS in April. The two additional cases, which took place during second phase trials in Korea, were reported in June and September respectively.

Boehringer Ingelheim has terminated its licence agreement to develop and market the drug outside of South Korea, China and Hong Kong.