Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
FDA Approval Summary: Tarlatamab for the Treatment of Extensive-Stage Small Cell Lung Cancer.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Liu Yufan, Nashed Jeannette, Barone Amy K, Yuan Mengdie, Amatya Anup K, Xiang Yue, Zhao Hong, Bi Youwei, Pegues Melissa A, Miller Claudia P, Lane Ashley R, Mixter Bronwyn D, Tang Shenghui, Pazdur Richard, de Claro R Angelo, Larkins Erin
Аннотация
On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (hereafter referred to as tarlatamab) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval was based on data from DeLLphi-301 (NCT05060016), an open-label, multicenter, multicohort trial involving patients with relapsed/refractory SCLC with disease progression after platinum-based chemotherapy and at least one other line of systemic therapy. Among 99 patients, the overall response rate (ORR) was 40% [95% confidence interval (CI), 31%-51%], with a median duration of response (DoR) of 9.7 months (range, 2.7-20.7+ months). The most common adverse reactions (≥20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea. Product labeling includes a Boxed Warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).