FDA revises monitoring for SCLC therapy

Initial monitoring decreases from 22 to 24 hours to 6 to 8 hours from the start of the first 2 infusions.

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The FDA updated tarlatamab-dlle prescribing information, reducing monitoring time after the first two doses for extensive-stage small cell lung cancer.
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Patients should now be monitored for 6 to 8 hours after the first two infusions, down from the previous 22 to 24 hours.
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Vital signs assessments are required the day after each of the first two doses, with specific monitoring times for subsequent doses.
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Tarlatamab is indicated for adults with extensive-stage small cell lung cancer after platinum-based chemotherapy.
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Cytokine release syndrome occurred in 57% of a pooled safety population, with neurologic toxicity reported in 65% of patients.

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