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FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer


Imdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer.

Lung banner vector for respiratory system smart healthcare. Image Credit: Adobe Stock Images/Rawpixel.com

Image Credit: Adobe Stock Images/Rawpixel.com

The FDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following treatment with platinum-based chemotherapy. According to the company, the regulatory action was based on the promising response rate and duration of response (DoR) with Imdelltra observed in clinical studies. The action represents the first and only T-cell engager therapy approved by the FDA for ES-SLCS, and Amgen stated that further indications for the use of Imdelltra could soon follow.1

"The FDA's approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients," said Jay Bradner, MD, EVP, research and development, chief scientific officer, Amgen, in a press release. "This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE) molecule. Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we're proud to deliver this long-awaited effective treatment to them."

The accelerated approval was based on findings from the Phase II DeLLphi-301 clinical trial, which evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen. Imdelltra achieved a 40% objective response rate, with a median duration of 9.7 months and overall survival of 14.3 months.1

"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years," said David P. Carbone, MD, PhD, professor of internal medicine, director, James Thoracic Oncology Center, Ohio State University Medical Center, in the press release. "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."

According to Medical News Today, around 65% of SCLC diagnoses are extensive, meaning that it has spread significantly since first forming. For the most part, survival rate is anywhere from two to four months. Current treatments, which typically offer a survival rate of up to 11 months, include chemotherapy and chemo-immunotherapy combination. However, surgery and radiation therapy aren’t necessarily an option due to how much the disease has progressed.2

The American Cancer Society reports that lung cancer is the second most common form of cancer in both men and women, with most diagnoses happening at 65 years of age and later. Lung cancer has been shown to be the leading cause of cancer death in the United States, as more people die of the condition than colon, breast, and prostate cancers combined.3

"After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available," said Laurie Fenton Ambrose, co-founder, president, CEO, GO2 for Lung Cancer. "Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease."


1. FDA APPROVES IMDELLTRA™ (TARLATAMAB-DLLE), THE FIRST AND ONLY T-CELL ENGAGER THERAPY FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER. Amgen. May 16, 2024. Accessed May 16, 2024. https://wwwext.amgen.com/newsroom/press-releases/2024/05/fda-approves-imdelltra-tarlatamabdlle-the-first-and-only-tcell-engager-therapy-for-the-treatment-of-extensivestage-small-cell-lung-cancer

2. What is the outlook for extensive small cell lung cancer? Medical News Today. Accessed May 16, 2024. https://www.medicalnewstoday.com/articles/prognosis-of-extensive-small-cell-lung-cancer

3. Key Statistics for Lung Cancer. American Cancer Society. Accessed May 16, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html

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