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The U.S. Food and Drug Administration (FDA) has declined to approve an antibody-drug conjugate known as HER3-DXd developed by Merck (NYSE:MRK) and Daiichi Sankyo (OTCPK:DSKYF) as a late-line option for a certain type of lung cancer.
The companies announced Thursday night that the agency issued a so-called complete response letter (CRL) in response to their biologics license application (BLA) seeking the FDA’s accelerated approval for HER3-DXd.
The BLA targeted its use in adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have undergone two or more prior therapies.
However, the regulator hasn’t raised concerns over the drug’s efficacy or safety as reasons for the rejection.
Instead, issues found in a third-party manufacturing facility led to the CRL, the companies said, adding that they would work with the FDA to resolve the concerns and bring HER3-DXd to the market.
The drug, also known as patritumab deruxtecan, formed part of a research and commercial collaboration worth up to $22B that Merck (MRK) and Daiichi (OTCPK:DSNKY) announced late last year.