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Patritumab Deruxtecan BLA Receives Priority Review in NSCLC

*December 2023*

The FDA has accepted and granted priority review to the biologics license application (BLA) seeking the approval of the HER3-directed antibody-drug conjugate (ADC) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC) who previously received at least 2 systemic therapies.1

“The acceptance of the BLA submission of patritumab deruxtecan marks an important step in potentially bringing this new medicine to previously treated patients with EGFR-mutated NSCLC, who often experience recurrence and have few remaining treatment options,” Marjorie Green, MD, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories, said in a press release. “Today is the first of many important milestones from our collaboration with Daiichi Sankyo, as we work together to bring new and potentially first-in-class ADCs to people living with cancer.”1

The regulatory decision was supported by findings from the phase 2 HERTHENA-Lung01 trial (NCT04619004), which enrolled patients with previously treated, locally advanced or metastatic NSCLC with EGFR activating mutations. Findings from the study, which were presented during the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the Journal of Clinical Oncology, showed that treatment with the ADC led to an overall response rate (ORR) of 29.8% (95% CI, 23.9%-36.2%) by blinded independent central review (BICR), with 1 complete response, among patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR-directed TKI and platinum-based chemotherapy (n = 225). Additionally, the median duration of response (DOR) was 6.4 months (95% CI, 4.9-7.8), and the median progression-free survival (PFS) was 5.5 months (95% CI, 5.1-5.9). Read more.