Pharma Focus Asia

ENHERTU® Receives Priority Review in the U.S. for Patients Diagnosed with Metastatic HER2 Positive Solid Tumors

Monday, January 29, 2024

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have received acceptance and Priority Review from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki). This application aims to seek approval for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have previously undergone treatment or have no satisfactory alternative options.

ENHERTU, a HER2-directed antibody-drug conjugate (ADC), is a collaborative effort between Daiichi Sankyo and AstraZeneca. The FDA granted Priority Review based on the potential significant improvements in safety or efficacy over existing treatments, with the Prescription Drug User Fee Act (PDUFA) date set for May 30, 2024. This follows the Breakthrough Therapy Designation received in August 2023 for ENHERTU in metastatic HER2-positive solid tumors.

The supplemental application is under review through the Real-Time Oncology Review (RTOR) program and Project Orbis, initiatives by the FDA designed to expedite the availability of effective cancer treatments. RTOR enables the FDA to assess components of the application before the complete submission, while Project Orbis facilitates simultaneous submission and review of oncology medicines internationally.

The application draws on data from the ongoing DESTINY-PanTumor02 phase 2 trial, demonstrating clinically meaningful and durable responses in previously treated patients with HER2-expressing advanced solid tumors. Additional data from supporting trials, including DESTINY-Lung01 and DESTINY-CRC02, were included in the submission.

Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, emphasized the potential of ENHERTU to extend beyond its current indications, and if approved, it could be the first tumor-agnostic therapy for HER2-positive tumors. Susan Galbraith, MBBChir, PhD, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the importance of defining HER2 expression biomarkers across various tumor types.

The DESTINY-PanTumor02 trial involves multiple tumor types, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer, or others, with confirmed objective response rate (ORR) as the primary endpoint. ENHERTU's potential is also being explored in trials such as DESTINY-Lung01 for non-small cell lung cancer and DESTINY-CRC02 for colorectal cancer.

ENHERTU, designed using Daiichi Sankyo’s DXd ADC technology, is approved in various countries for different indications, including HER2-positive breast cancer, HER2 low breast cancer, NSCLC with HER2 mutations, and HER2-positive gastric or gastroesophageal junction adenocarcinoma. The ongoing trials aim to expand its usage across multiple tumor types, reinforcing its potential as a groundbreaking treatment option.



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