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  • Amgen¡¯s SCLC drug tarlatamab soon to be approved in KOR
  • by Lee, Hye-Kyung | translator Alice Kang | May 26, 2025 05:55am
Amgen submits a new drug application last year¡¦ MFDS completes safety and efficacy review

The approval of Amgen's new drug for small cell lung cancer, tarlatamab (U.S. brand name Imdelltra), is imminent in Korea.

According to industry sources on the 23rd, the Ministry of Food and Drug Safety has completed its safety and efficacy review for tarlatamab. The MFDS's completion of the review means a new drug approval will follow soon.

Tarlatamab was designated as a ¡°GIFT¡± item by the MFDS in January last year and underwent a fast-track review upon the submission of the new drug application.

In the United States, the FDA designated tarlatamab as breakthrough therapy in October 2023 and granted accelerated approval on May 16, 2024, for the treatment of adult patients with extensive-stage small cell
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