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Investing.com -- Pharmaceutical (TADAWUL:2070) companies, Daichii Sankyo and Merck (NSE:PROR), on Thursday made the decision to pull back their Biologics License Application (BLA) that sought expedited U.S. approval for the drug patritumab deruxtecan (HER3-DXd).
This withdrawal comes in the wake of the Herthena-Lung02 phase 3 trial’s topline overall survival results, which failed to achieve statistical significance.
Furthermore, this decision was influenced by dialogues with the U.S. Food and Drug Administration (FDA).
It’s important to note that this decision is not connected to the Complete Response Letter (CRL) received in June 2024.
The CRL outlined findings from an inspection of a third-party manufacturing facility.
The safety profile for patritumab deruxtecan in the Herthena-Lung02 trial was found to be consistent with the safety profile observed in previous lung cancer trials involving the same drug.
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