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  • SCLC drug tarlatamab may soon be introduced in KOR
  • by Eo, Yun-Ho | translator Kang, Shin-Kook | Aug 21, 2024 05:48am
An area that lacked a treatment option
Amgen Korea is receiving MFDS review for the drug in Korea
FDA accelerated approval of tarlatamab based on results from the Phase II DeLLphi-301 clinical trial

Amgen is preparing to introduce its new small cell lung cancer drug tarlatamab in Korea.

According to industry sources, Amgen Korea has submitted an application for tarlatamab, its bispecific antibody for small cell lung cancer, to the Ministry of Food and Drug Safety and is undergoing review.

The drug was designated the first orphan drug of the new year in January and received accelerated approval from the U.S. FDA in May.

Tarlatamab is a bispecific antibody that recognizes antigens in both tumor cells and T cells (immune cells). This allows for the drug to induce T cells to attack tumor cells even when the tumor cells try to avoid them.

The drug¡¯s efficacy was demonstrated in the Phase II DeLLphi-301
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