AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC

{
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  "detected_at": "2026-10-07T12:30:00+00:00",
  "company": {
    "name": "AbbVie",
    "domain": "abbvie.com"
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  "data": {
    "url": "https://www.prnewswire.com/news-releases/abbvies-telisotuzumab-adizutecan-temab-a-receives-two-breakthrough-therapy-designations-from-the-us-fda-for-crc-and-nsclc-302900512.html",
    "title": "AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC",
    "excerpt": "NORTH CHICAGO, Ill. , Oct. 7, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV ) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404 ( NCT05029882 ). \"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors,\" said Eleni Lagkadinou, M.D., Ph.D., vice president, oncology early development, AbbVie. \"As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations. We believe...",
    "product": "telisotuzumab adizutecan",
    "summary": "AbbVie is developing telisotuzumab adizutecan (Temab-A; ABBV-400), an investigational antibody-drug conjugate for CRC and NSCLC which received two FDA Breakthrough Therapy Designations.",
    "location": "North Chicago, Illinois, USA",
    "planning": true,
    "confidence": 0.95,
    "product_data": {
      "name": "telisotuzumab adizutecan",
      "full_text": "telisotuzumab adizutecan (Temab-A; ABBV-400)",
      "fuzzy_match": false
    },
    "product_tags": [
      "medical"
    ],
    "published_at": "2026-10-07T12:30:00Z",
    "location_data": [
      {
        "city": "North Chicago",
        "state": "Illinois",
        "region": "Northern America",
        "country": "United States",
        "continent": "Americas",
        "fuzzy_match": false
      }
    ],
    "effective_date": "2026-10-07",
    "article_sentence": "AbbVie (NYSE: ABBV ) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC)."
  }
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