In a significant regulatory development, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of patritumab deruxtecan (HER3-DXd), co-developed by Daiichi Sankyo (TSE: 4568) and Merck & Co. (known as MSD outside of the United States and Canada) (NYSE: MRK). The BLA sought accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously undergone therapy.
The issuance of the CRL follows inspectional findings at a third-party manufacturer involved in the production of patritumab deruxtecan. These findings, which have not been publicly detailed, were significant enough to raise concerns about the manufacturing process, ultimately prompting the FDA to withhold approval at this time.
This development could be seen as a setback for both Daiichi Sankyo and Merck & Co. especially given the crowded and competitive landscape of treatments targeting NSCLC, a prevalent and challenging form of cancer. Accelerated approval would have allowed patritumab deruxtecan to reach patients sooner, highlighting the importance of manufacturing compliance in addition to clinical efficacy and safety.
In a related financial context, Merck & Co. reported a 7.38% decline in revenues from its suppliers compared to the same quarter last year. However, sequentially, the company’s sales showed a positive trend with a 9.69% increase. Cost of sales experienced a year-on-year deterioration of 9.83%, although there was a sequential improvement, with a 9.51% reduction in Q1 costs.
The dual challenge of regulatory approval delays and fluctuating financial metrics puts additional pressure on Merck & Co. as it strives to maintain its market position and continue advancing its oncology drug pipeline.
As Daiichi Sankyo and Merck & Co. address the FDA’s concerns, the importance of robust manufacturing practices and stringent quality controls will likely remain at the forefront of their operational strategies. Stakeholders and healthcare professionals alike will be keenly observing how the companies navigate these challenges to bring new, effective treatments to patients in need.
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