BioPharma Dive May 17, 2024
Jonathan Gardner

A bispecific antibody, Imdelltra is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.

Dive Brief:

  • The Food and Drug Administration on Thursday granted accelerated approval to a new dual-acting drug from Amgen to treat small cell lung cancer in people whose disease has progressed following chemotherapy.
  • The drug, which will be sold as Imdelltra, is an immunotherapy that helps T cells home in on tumor cells by binding to protein flags on the surface of both. It is the tenth so-called “bispecific” antibody to gain FDA approval in cancer, and the first in small cell lung cancer.
  • The FDA approved Imdelltra more than three weeks ahead of its deadline, and based its decision on a...

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