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FDA Grants Approval for IMDELLTRA™ (Tarlatamab-dlle): First T-cell Engager Therapy for Extensive-Stage Small Cell Lung Cancer

NextEdge Admin

18 May 2024

3 min 1 sec

Amgen’s IMDELLTRA™ (tarlatamab-dlle) has gained FDA approval for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) post platinum-based chemotherapy progression. This milestone reflects a significant advancement, offering hope to a patient population with limited treatment options.

The approval is based on compelling data from the Phase 2 DeLLphi-301 trial, showcasing IMDELLTRA’s efficacy in patients who had undergone two or more prior lines of treatment. Notably, the therapy demonstrated a 40% objective response rate (ORR) and a median duration of response (DoR) of 9.7 months. Moreover, the median overall survival (mOS) reached 14.3 months, with durable responses observed, indicating a notable shift in the treatment landscape for ES-SCLC.

IMDELLTRA operates as a DLL3-targeting Bispecific T-cell Engager therapy, harnessing the patient’s T cells to combat DLL3-expressing tumor cells. This mechanism offers a targeted approach with promising results, particularly in a disease where therapeutic advancements have been historically scarce.

Despite its efficacy, IMDELLTRA comes with important safety considerations, including cytokine release syndrome (CRS) and neurologic toxicity, emphasizing the need for careful monitoring and management of adverse events.

Amgen’s commitment extends beyond drug development, with a focus on patient support and access. Through initiatives like Amgen® SupportPlus and the Amgen Safety Net Foundation, the company aims to ensure that eligible patients can access IMDELLTRA, irrespective of insurance coverage.

The FDA’s accelerated approval underscores the urgent need for innovative therapies in ES-SCLC and represents a significant milestone for patients, caregivers, and the medical community alike. As such, Amgen plans to host an investor call to discuss the implications and future prospects of IMDELLTRA’s approval, highlighting its strategic importance within the company’s portfolio.

The approval of IMDELLTRA heralds a new era in ES-SCLC treatment, offering a targeted and effective therapeutic option that addresses an unmet medical need and provides renewed hope for patients facing this aggressive disease.