The sBLA for the drug Enhertu (trastuzumab deruxtecan) has been acknowledged and given Priority Review by the US Food and Drug Administration (FDA).
The application seeks approval for treating adults with unresectable or metastatic HER2-positive solid tumors (IHC 3+) who have undergone prior treatment or lack satisfactory alternative options.
The submission is grounded in data from the ongoing DESTINY-PanTumor02 Phase II trial. Enhertu, a HER2-directed antibody drug conjugate (ADC), showcased substantial and enduring responses, leading to a clinically significant survival advantage in previously treated patients across various HER2-expressing metastatic solid tumors, including biliary tract, bladder, cervical, endometrial, and ovarian cancers.
Supporting trials such as DESTINY-Lung01 and DESTINY-CRC02, focusing on patients with HER2-positive IHC3+ tumors within the Enhertu clinical development program, were also incorporated in the submission.
The Prescription Drug User Fee Act date, the FDA’s decision deadline, is set for the second quarter of 2024.
In a statement, Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology R&D, highlighted the significance of the Priority Review for Enhertu’s pioneering tumor-agnostic submission.
Galbraith emphasized that this milestone underscores the potential of Enhertu to redefine HER2-expressing cancer treatment. While HER2 expression biomarkers are well-established in breast and gastric cancers, efforts are underway to extend their definition across various tumor types.
Galbraith also expressed the commitment to collaborating closely with the FDA to expedite the delivery of this potentially groundbreaking tumor-agnostic HER2-targeted medicine and associated biomarker to patients.
According to Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, the clinical advantages observed in the DESTINY-PanTumor02 trial across HER2-expressing metastatic solid tumors, coupled with ongoing data from the Enhertu clinical development program, persistently underscore the broader potential of this medication beyond its current approved uses.
Takeshita noted that if approved, Enhertu has the potential to be the inaugural HER2-directed therapy and antibody-drug conjugate with a tumor-agnostic indication, offering patients a prospective alternative in treatment.
Source: Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-granted-priority-review-in-the-us-for-patients-with-metastatic-her2-positive-solid-tumours.html
