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# Accelerated Approval for Amgen Lung Cancer Drug
- URL: https://www.fdaweb.com/accelerated-approval-for-amgen-lung-cancer-drug/
- Published: 2024-05-16T12:00:00.000Z
- Updated: 2026-09-14T14:31:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157005

FDA has granted Amgen accelerated approval for its BLA for Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Approval was based on data from DeLLphi-301 \[NCT05060016\] clinical trial in 99 patients, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery). The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR). “ORR was 40% (95% CI: 31, 51) and median DOR was 9.7 months…,” it says. “Of the 69 patients with available data regarding platinum sensitivity status, the ORR was 52% (95% CI 32, 71) in 27 patients with platinum-resistant SCLC (defined as progression less than 90 days after last dose of platinum therapy) and 31% (95% CI 18, 47) in 42 patients with platinum-sensitive SCLC (defined as progression greater than 90 days after last dose of platinum therapy).”

FDA notes that the therapy’s prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. The most common adverse reactions (occurring in over 20% of patients treated) were CRS, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.