Merck : FDA Issues Complete Response Letter For Patritumab Deruxtecan In EGFR-Mutated NSCLC

(RTTNews) - The U.S. Food and Drug Administration issued a Complete Response Letter or CRL for the Biologics License Application or BLA seeking accelerated approval of Daiichi Sankyo (DSKYF.PK) and Merck's (MRK) patritumab deruxtecan or HER3-DXd for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer or NSCLC previously treated with two or more systemic therapies.

The CRL results from findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted, the companies said.

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate or ADC discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.

Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI.

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