A HER3 targeting DXd antibody-drug conjugate (ADC), patritumab deruxtecan is intended for usage in patients with locally advanced or metastatic EGFR-mutated NSCLC, who have been treated with two or more systemic treatments earlier.
The regulatory agency accepted the BLA, with a decision on the drug approval anticipated on 26 June 2024.
The latest development comes after the FDA awarded breakthrough therapy designation for patritumab deruxtecan in December 2021.
Patritumab deruxtecan is being reviewed under the regulator’s Real-Time Oncology Review (RTOR) programme, intended to offer efficient cancer therapies rapidly by permitting for the review of application components before the full application is submitted.
The BLA is supported by initial data from the Phase II HERTHENA-Lung01 clinical trial of patritumab deruxtecan.
The multicentre, international, open-label trial is designed to evaluate the efficacy and safety of patritumab deruxtecan in 225 EGFR-mutated locally advanced or metastatic NSCLC patients enrolled from across Asia, Europe, North America, and Oceania.
According to the findings, the patritumab deruxtecan treatment offered a 29.8% objective response rate (ORR) with 6.4 months of median duration of response.
The safety profile of patritumab deruxtecan was reported to be in line with those seen in prior Phase I trials in NSCLC.
Daiichi Sankyo R&D global head Ken Takeshita said: “The FDA’s prioritisation of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasises the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies.
“If approved, patritumab deruxtecan could become the first HER3-directed medicine approved in the US and the second DXd antibody drug conjugate approved from Daiichi Sankyo’s oncology pipeline.”
In October this year, Daiichi Sankyo and Merck signed an international partnership for the co-development and marketing of patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan for territories excluding Japan.
Daiichi Sankyo will hold the sole rights for the products in Japan and will also carry out their production and supply.