Amgen’s SCLC drug tarlatamab soon to be approved in KOR

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 lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

 

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.

 

This drug demonstrated efficacy in the Phase II DeLLphi-301 trial.

 

The trial evaluated the efficacy of tarlatamab in patients with SCLC who had failed two or more prior lines of treatment.

 

The patients that enrolled in the trial received tarlatamab 10 mg every two weeks.

 

The team recruited and randomized 220 patients who had failed first-line treatment for small cell lung cancer at 56 centers in 17 countries around the world, to find a new treatment strategy that would maximize the effectiveness of tarlatamab, which is currently under development while maintaining patient safety.

 

Results showed that the group of subjects who received tarlatamab 100 mg every 2 weeks achieved an objective response rate of 40%, with a median response duration of 9.7 months.

 

The median overall survival was 14.3 months.

 

Currently, available treatments for small cell lung cancer in Korea include the immunotherapy drug 'Imfinzi (durvalumab)' and the chemotherapy drug ‘Zepzelca (lurbinectedin).'