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Tarlatamab

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Tarlatamab

Tarlatamab, sold under the brand name Imdelltra, is an anti-cancer medication used for the treatment of extensive-stage small cell lung cancer. It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3.

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.

Tarlatamab was approved for medical use in the United States in May 2024. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

Tarlatamab is indicated for the treatment of adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The prescribing information for tarlatamab includes a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, as well as warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity.

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.

Efficacy was evaluated in 99 participants with relapsed/refractory extensive stage small cell lung cancer with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study. Participants with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Participants received tarlatamab until disease progression or unacceptable toxicity.

The US Food and Drug Administration (FDA) granted the application for tarlatamab priority review, breakthrough therapy, and orphan drug designations.

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