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Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal

Merck and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application for ifinatamab deruxtecan (I-DXd) intended to treat adult patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). The decision follows discussions with the FDA, which determined that data from the IDeate-Lung01 Phase 2 trial did not meet the requirements for accelerated approval. While this application is scrapped, the companies are continuing patient enrollment in the Phase 3 IDeate-Lung02 trial to evaluate the drug against physician-selected chemotherapy.

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⚡ Key Developments & Real-Time Context
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  • ✓ Merck and Daiichi Sankyo voluntarily withdrew the Biologics License Application for ifinatamab deruxtecan in adult patients with extensive-stage small cell lung cancer.
  • ✓ The FDA stated the companies lacked sufficient data for accelerated approval, including data from the IDeate-Lung01 Phase 2 trial.
  • ✓ Patient enrollment is continuing in the IDeate-Lung02 Phase 3 trial comparing the drug to chemotherapy.
  • ✓ The withdrawal impacts a $4B deal between the two firms.
🛡️ Source Corroboration: 17 independent reporting domains (100% confidence) ⏱ Read time: ~2 min

What changed

Merck and Daiichi Sankyo retracted their request for accelerated FDA approval of ifinatamab deruxtecan for ES-SCLC.

Live updates

  1. Merck and Daiichi Sankyo Withdraw Lung Cancer Drug Application After FDA Pushback

    Merck and Daiichi Sankyo have voluntarily withdrawn their Biologics License Application for ifinatamab deruxtecan (I-DXd) intended to treat adult patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). The decision follows discussions with the FDA, which determined that data from the IDeate-Lung01 Phase 2 trial did not meet the requirements for accelerated approval. While this application is scrapped, the companies are continuing patient enrollment in the Phase 3 IDeate-Lung02 trial to evaluate the drug against physician-selected chemotherapy.

    Why it matters

    This setback affects a $4B partnership between the two companies and represents the second partnered cancer therapy application they have pulled in the US. RBC Capital Markets suggests the withdrawal benefits competitors like Roche and GSK. The drug is a B7-H3 antibody-drug conjugate.

    What is confirmed

    • Merck and Daiichi Sankyo voluntarily withdrew the Biologics License Application for ifinatamab deruxtecan in adult patients with extensive-stage small cell lung cancer.
    • The FDA stated the companies lacked sufficient data for accelerated approval, including data from the IDeate-Lung01 Phase 2 trial.
    • Patient enrollment is continuing in the IDeate-Lung02 Phase 3 trial comparing the drug to chemotherapy.
    • The withdrawal impacts a $4B deal between the two firms.

    Still unconfirmed

    • RBC Capital Markets views the withdrawal as a net positive for rivals GSK and Roche.
    • The withdrawal is a setback for the HER3 programme ahead of a data readout at ASCO.

    What to watch next

    • Results from the IDeate-Lung02 Phase 3 trial
    • Data readout at ASCO regarding the HER3 programme
    Sources used for this update (21)
    1. Fierce Biotech — Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal
    2. Reuters — Merck, Daiichi pull US application for second partnered cancer therapy
    3. OncLive — Ifinatamab Deruxtecan BLA Voluntarily Withdrawn in Previously Treated Extensive-Stage SCLC
    4. Endpoints News — Merck, Daiichi scrap FDA application for B7-H3 ADC in lung cancer
    5. FirstWord — Vital Signs: Twice bitten, thrice shy for Merck and Daiichi's ADC aspirations
    6. BioSpace — Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC
    7. www.merck.com — Merck | Home
    8. jobs.merck.com — Discover Job Opportunities at Merck | Merck Careers
    9. jobs.merck.com — Your job search results | Merck Careers
    10. www.merck.com — Products list - Merck.com
    11. www.fiercebiotech.com — Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal | Fierce Biotech
    12. www.merck.com — Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensiv....
    confidence 100%
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