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FDA grants traditional approval to Amgen’s Imdelltra for ES-SCLC

The Food and Drug Administration granted traditional approval to tarlatamab-dlle, or Imdelltra, from Amgen (AMGN) for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024, the FDA noted.

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