Amgen’s Breakthrough DLL3-Targeting Therapy ‘IMDELLTRA’ Approved for Extensive-Stage SCLC Treatment
In a pivotal DeLLphi-301 study, Amgen’s IMDELLTRA therapy demonstrated a remarkable 40% objective response rate, with a median duration of response of 9.7 months and a median overall survival of 14.3 months in patients with extensive-stage small cell lung cancer (ES-SCLC) who progressed after platinum-based chemotherapy. The FDA has granted accelerated approval for IMDELLTRA based on these positive clinical outcomes, and further approval is subject to confirmation in confirmatory trials.
This innovative therapy, designed to target DLL3-expressing tumor cells, activates the patient’s own T cells to attack cancer cells. The approval of IMDELLTRA is a significant milestone for ES-SCLC patients, offering hope for those in urgent need of effective treatments.
The pivotal study also highlighted the significant impact of IMDELLTRA, with responses being durable and representing a major advancement in SCLC treatment. The therapy also comes with a Boxed Warning for cytokine release syndrome and neurologic toxicity, among other safety precautions.
Amgen will be hosting a webcast investor call on May 20, 2024, to discuss the FDA approval of IMDELLTRA and its implications. This approval marks a transformative step in addressing aggressive cancers and delivering effective treatments to patients in need.
For more information, please visit Amgen’s official website.
Vocabulary List:
- Breakthrough (noun): A significant development or achievement.
- Therapy (noun): Treatment intended to relieve or heal a disorder.
- Extensive-Stage (adjective): Describing the spread or severity of cancer.
- Remarkable (adjective): Worthy of attention or extraordinary.
- Accelerated (adjective): Increased speed or progress.
- Confirmatory (adjective): Providing further validation or affirmation.
