The FDA has granted two Breakthrough Therapy designations to telisotuzumab adizutecan, or Temab-A, an experimental AbbVie drug for advanced colorectal and lung cancers, the company announced in a press release on Oct. 7. The status can speed the drug's development and review, but it is not an approval.
One designation covers Temab-A combined with bevacizumab for adults with metastatic colorectal cancer that keeps progressing after standard chemotherapy and targeted drugs. The other covers Temab-A alone for adults with advanced non-squamous non-small cell lung cancer that is EGFR wild-type and expresses the c-Met protein, after platinum chemotherapy and immunotherapy.
