{
  "id": 9831251,
  "title": "Daiichi Sankyo and Merck withdraw lung cancer drug application",
  "url": "https://urgent.news/2026/09/25/daiichi-sankyo-and-merck-withdraw-lung-cancer-drug-application",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-25T20:36:34.000Z",
  "source": {
    "name": "Investing.com",
    "slug": "investing-com",
    "url": "https://www.investing.com/news/company-news/daiichi-sankyo-and-merck-withdraw-lung-cancer-drug-application-93CH-4918112"
  },
  "original_language": "en",
  "account": "Daiichi Sankyo and Merck have chosen to withdraw their Biologics License Application for an experimental lung cancer drug in the United States. The drug, ifinatamab deruxtecan, was meant to treat advanced small cell lung cancer. The withdrawal came after discussions with the FDA, where the companies learned that their data from a Phase 2 trial did not meet the necessary standards for accelerated approval. The application aimed to help patients who had already gone through platinum-based chemotherapy and whose cancer had worsened. However, enrollment in the next Phase 3 trial is nearly finished, and the companies are optimistic about future filings with the FDA and other global regulators based on the results of that trial. Both companies are also running other Phase 3 trials with ifinatamab deruxtecan for advanced or metastatic cancers, including prostate and esophageal cancers. This drug, an antibody-drug conjugate, has been given a special designation by the FDA for treating small cell lung cancer. Small cell lung cancer affects about 12% of all lung cancer diagnoses in the United States.",
  "summary": null,
  "key_points": [
    "Daiichi Sankyo and Merck withdraw ifinatamab deruxtecan application in US.",
    "FDA discussions revealed trial data did not meet accelerated approval standards.",
    "Future filings with FDA and global regulators optimistic based on Phase 3 trial results."
  ],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}