FDA issues complete response to Daiichi Sankyo-MSD's BLA for NSCLC [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
NASDAQ:AMEX Investor Relations:
daiichisankyo.com/media_investors/investor_relations/index.html
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Source: Yahoo! Finance
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 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.” The BLA was based on initial results from the multicentre, global, open-label, two-arm Phase
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