Tuesday, April 16, 2024

FDA Awards Priority Review to Daiichi Sankyo-Merck’s Treatment for Lung Cancer

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The US FDA has given priority review to Daiichi Sankyo and Merck’s application for patritumab deruxtecan, a potential therapy for non-small cell lung cancer (NSCLC) in adults. This review aims to assess its efficacy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received at least two prior systemic treatments. The decision on its approval is expected by June 26, 2024.

Patritumab deruxtecan is a HER3-targeting DXd antibody-drug conjugate (ADC) undergoing evaluation under the Real-Time Oncology Review (RTOR) program. This program expedites the review process by allowing components of the application to be assessed before the complete submission.

Lung Cancer

Breakthrough Designation and Promising Phase II Trial in Lung Cancer

The breakthrough therapy designation was granted to patritumab deruxtecan in December 2021, propelling its evaluation forward. The basis of the Biologics License Application (BLA) hinges on initial data from the Phase II HERTHENA-Lung01 trial. This international study involves 225 patients with EGFR-mutated locally advanced or metastatic NSCLC across various regions.

Early results indicate a 29.8% objective response rate (ORR) and a median duration of response of 6.4 months, illustrating the therapy’s potential in this patient population. The FDA’s prioritized review signifies a significant step toward potentially approving a promising treatment option for NSCLC, addressing the critical need for therapies in the advanced stages of this disease.


Resource: Pharmaceutical Business Review, December 26, 2023

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