To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events
Fierce Pharma
AUGUST 13, 2024
When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.
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