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On Wednesday, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and Merck & Co Inc’s (NYSE:MRK) patritumab deruxtecan (HER3-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
The CRL results from findings about an inspection of a third-party manufacturing facility.
The CRL did not identify any issues with the efficacy or safety data submitted.
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
In December, the FDA accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd).
If approved, patritumab deruxtecan would be a first-in-class HER3-directed DXd antibody-drug conjugate for these patients.
“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,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain confident in the ability to develop this medicine to its full potential.”
The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial.
In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients, which demonstrated an objective response rate (ORR) of 29.8%, including one complete response and 66 partial responses.
The median duration of response (DoR) was 6.4 months.
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Price Action: At the last check on Thursday, MRK shares were down 1.04% at $130.14.
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