Thursday, 19 January 2017 15:01

South Korea Maintains Approval For Sale Of Contentious Cancer Medication

The attention of the Agency has been drawn to the South Korea Ministry of Food and Drug Safety (MFDS) resolution to maintain approval for the sale of Contentious lung cancer treatment medication called Olmutinib sold under the Trade Name Olita Tab.

Olmutinib, also known as HM61713 or BI14829 a third-generation lung cancer therapy has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer, who had been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

It has been a breakthrough therapy for patients who have developed a tolerance to existing lung cancer treatments. The ministry however, stressed that Healthcare providers should receive consent form from patients before using the drug, in order to provide a treatment opportunity for patients who have no alternative treatment.


  • Manufacturer: Hanmi Pharmaceuticals Company, South Korea.
  • Drug name: Olmutinib sold under the trade name Olita Tab.

In view of this, the:

Patients taking Olmutinib should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.

Healthcare professionals are implored to report adverse effect or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.


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