Pharmaceutical Executive May 17, 2024
Don Tracy, Associate Editor

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

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...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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