KENILWORTH (NJ) (dpa-AFX) - 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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