JHVEPhoto
The US Food and Drug Administration (FDA) has refused to approve an antibody-drug conjugate known as HER3-DXd developed by Merck (New York Stock Exchange: MRK) and Daiichi Sankyo (OTCPK:DSKYF) as a late option for certain types of lung cancer.
The companies announced Thursday The night the agency issued a so-called complete response letter (CRL) in response to its biologics license application (BLA) seeking accelerated FDA approval for HER3-DXd.
The BLA focused on its use in adults with EGFR-mutated locally advanced or metastatic non-small cell lung cancer who have undergone two or more prior therapies.
However, the regulator has not raised concerns about the drug's efficacy or safety as reasons for the rejection.
Instead, problems found at a third-party manufacturing facility led to the CRL, the companies said, adding that they would work with the FDA to resolve concerns and bring HER3-DXd to market.
The drug, also known as patritumab deruxtecan, was part of a research and commercial collaboration worth up to $22 billion that Merck (MRK) and Daiichi (OTCPK:DSNKY) announced late last year.
