The Ministery of Food and Drug Safety said on the 20th that it approved a new targeted therapy, Huneuo tablets (ingredient name: sevabertinib), for patients with a rare lung cancer.
Huneuo, developed by Germany's Bayer, won approval from the U.S. Food and Drug Administration (FDA) in Nov. last year.
Huneuo tablets are an oral targeted anticancer drug (TKI) that specifically targets lung cancers with HER2 gene alterations. The alteration sends signals that keep cancer cells growing, and the drug blocks these signals to suppress tumor growth.
Eligible patients are those with non-squamous Non-small cell lung cancer (NSCLC) who have already received at least one anticancer treatment and whose disease has progressed or metastasized to other organs.
The approval was expedited. The Ministery of Food and Drug Safety designated the drug under the Global Innovative product Fast Track (GIFT) support system and accelerated its review. The program shortens review times for therapies for life-threatening diseases or rare diseases that are recognized as innovative, to improve patient access.
The Ministery of Food and Drug Safety said it will continue to work to quickly introduce treatments whose safety and effectiveness have been confirmed to broaden patients' treatment opportunities.