(RTTNews) - AstraZeneca (AZN, AZN.L) and Daiichi Sankyo said that they have received notification of acceptance of the supplemental Biologics License Application of ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients in the U.S. with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
ENHERTU is a HER2 directed antibody drug conjugate being jointly developed by Daiichi Sankyo and AstraZeneca.
The application is based on data from the pivotal DESTINY-Lung01 phase 2 trial and is supported by the phase 1 trial.
Based on pivotal DESTINY-Lung01 results showing Daiichi Sankyo and AstraZeneca's ENHERTU demonstrated a 54.9% tumor response rate.
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