The US Food and Drug Administration (FDA) has provided a complete response letter for and MSD’s biologics licence application (BLA) seeking approval for patritumab deruxtecan (HER3-DXd) to treat non-small cell lung cancer (NSCLC). The BLA sought accelerated approval for the antibody-drug conjugate for adults with locally advanced or metastatic EGFR [epidermal growth factor receptor]-mutated NSCLC previously treated with two or more systemic therapies. The gold standard of business intelligence.
The regulator highlighted inspection findings at a third-party manufacturing facility. The letter did not query the submitted efficacy or safety data for patritumab deruxtecan. Daiichi Sankyo research and development global head Ken Takeshita stated: “We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3-directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer.
“We remain confident in the ability to develop this medicine to its full potential.” Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The BLA was based on.
