The Ministry of Food and Drug Safety announced on the 30th that it has approved the progressive small cell lung cancer treatment ‘IMDELLTRA (IMDELLTRA®; ingredient name talatomab)’ by the American company Amgen.
Lung cancer is classified as small cell lung cancer when the cancer cells are small and non-small cell lung cancer when they are larger. Small cell lung cancer accounts for about 15-25% of all lung cancer patients, but it is more aggressive and has a higher fatality rate than non-small cell lung cancer, which makes up 85% of all lung cancers.
IMDELLTRA is the first dual-antibody new drug that activates the patient’s immune cells (T cells) to target delta-like ligand 3 (DLL3), which is expressed in 90% of small cell lung cancer patients. It received accelerated approval from the U.S. Food and Drug Administration (FDA) last May and was launched. Accelerated approval is a system for rapidly introducing new drug candidates in clinical phases 2 and 3 for diseases with limited treatment options, allowing for formal approval once additional clinical data is secured.
IMDELLTRA is a treatment for adult patients with recurrent or refractory extensive small cell lung cancer who have received second-line treatment or more, including chemotherapy. It is the first approved third-line treatment for small cell lung cancer in Korea, opening new treatment opportunities for patients.
The Ministry of Food and Drug Safety previously designated IMDELLTRA as the 25th product of the GIFT program, which supports the rapid commercialization of globally innovative treatments from the early stages of development, and conducted a rapid review.
A Ministry of Food and Drug Safety official noted, ‘We will continue to do our best to ensure that new treatments are rapidly supplied to patients with rare and difficult-to-treat diseases based on regulatory science expertise, expanding treatment opportunities.’