Daiichi Sankyo and Merck Withdraw Lung Cancer Drug Application After FDA Concerns — Daiichi Sankyo Company, Limited

Event summary

Daiichi Sankyo and Merck voluntarily withdrew the Biologics License Application (BLA) for ifinatamab deruxtecan in treating extensive-stage small cell lung cancer (ES-SCLC) after FDA deemed the data insufficient for accelerated approval.
The decision follows discussions with the FDA regarding the IDeate-Lung01 phase 2 trial data, which did not meet the required standards.
Patient enrollment continues in the IDeate-Lung02 phase 3 trial, evaluating ifinatamab deruxtecan against chemotherapy in relapsed ES-SCLC.
Ifinatamab deruxtecan is a B7-H3 directed antibody drug conjugate (ADC) jointly developed by Daiichi Sankyo and Merck.

The big picture

The withdrawal highlights the stringent requirements for accelerated approval in oncology, particularly for treatments targeting aggressive cancers like ES-SCLC. The setback could impact Daiichi Sankyo and Merck's timeline for bringing ifinatamab deruxtecan to market, but the ongoing phase 3 trials suggest continued investment in the drug's potential. The broader industry trend of leveraging antibody drug conjugates (ADCs) for difficult-to-treat cancers remains a key focus for both companies.

What we're watching

Regulatory Pathway: Whether the IDeate-Lung02 phase 3 trial results will meet FDA standards for future approval filings.
Clinical Development: The pace at which additional phase 3 trials for ifinatamab deruxtecan in other cancer types progress.
Strategic Collaboration: How Daiichi Sankyo and Merck's joint development efforts will adapt following this setback.