Tuesday, April 16, 2024

Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors

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AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.

The sBLA is based on data from the ongoing DESTINY-PanTumor02 Phase II trial where Enhertu demonstrated clinically meaningful and durable responses leading to a clinically meaningful survival benefit in previously treated patients across HER2-expressing metastatic solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian cancers, and other tumors. Data from other supporting trials in patients with HER2-positive IHC3+ tumors in the Enhertu clinical development program, including DESTINY-Lung01 and DESTINY-CRC02, were also included in the submission. Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the second quarter of 2024.

Revolutionizing Cancer Care: Enhertu’s Promising Tumor-Agnostic Advancements

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers. Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. We will continue working closely with the FDA to bring this potential first tumor-agnostic HER2-targeted medicine and biomarker to patients as quickly as possible.”

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: “The clinical benefit seen across HER2-expressing metastatic solid tumors in the DESTINY-PanTumor02 trial and ongoing data from the Enhertu clinical development program continues to demonstrate the potential of this medicine beyond its approved indications. If approved, Enhertu could become the first HER2-directed therapy and antibody-drug conjugate with a tumor-agnostic indication, providing patients with a potential new treatment option.”

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA that are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Results from DESTINY-PanTumor02 were presented at the 2023 European Society for Medical Oncology Congress and simultaneously published in the Journal of Clinical Oncology. The safety profile observed across the trials was consistent with previous clinical trials of Enhertu with no new safety concerns identified. The Priority Review follows receipt of Breakthrough Therapy Designation (BTD) in the US in August 2023 for Enhertu in metastatic HER2-positive solid tumors.

If approved, AstraZeneca and Daiichi Sankyo’s Enhertu will potentially be the first HER2-directed treatment and antibody-drug conjugate to receive a tumor-agnostic indication. This marks a significant milestone in cancer treatment, offering a potential new therapy for patients with HER2-positive solid tumors who have limited treatment options.

Priority Review

Elevating Hope: Enhertu’s Potential Breakthrough in HER2-Positive Solid Tumor Treatment

The submission of the supplemental Biologics License Application for Enhertu is based on promising data from the ongoing DESTINY-PanTumor02 Phase II trial, which has shown clinically meaningful and durable responses in patients with HER2-expressing metastatic solid tumors. These results suggest that Enhertu could provide a viable treatment option for patients who have previously received treatment and for those who have exhausted other available options. Enhertu is a novel HER2-directed antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo. It has shown significant potential in treating a variety of HER2-positive solid tumors, including biliary tract, bladder, cervical, endometrial, and ovarian cancers.

The Priority Review granted by the FDA signifies the potential of Enhertu to bring about a paradigm shift in the treatment of HER2-expressing cancers. It reflects the urgency of addressing the unmet medical needs of patients with limited treatment options. If approved, Enhertu will become the first tumor-agnostic HER2-targeted medicine and biomarker, underscoring its importance in advancing personalized cancer therapy. The clinical benefit demonstrated by Enhertu in the DESTINY-PanTumor02 trial, which includes a wide range of HER2-expressing metastatic solid tumors, offers hope for patients facing these aggressive and challenging cancers. The survival benefit observed with Enhertu marks a significant advancement in the field of oncology and underscores the potential of this innovative therapy.

The acceptance of the sBLA for Priority Review is a significant step toward making Enhertu available as a potential first-line treatment option for patients with unresectable or metastatic HER2-positive solid tumors. It is a testament to the collaborative efforts of AstraZeneca and Daiichi Sankyo in bringing innovative therapies to patients with limited treatment options. The FDA’s Priority Review designation is a recognition of the potential of Enhertu to improve patient outcomes and address unmet medical needs. If approved, Enhertu could become the first HER2-directed therapy and antibody-drug conjugate to receive a tumor-agnostic indication, representing a major milestone in cancer treatment.

The submission of the sBLA for Enhertu is supported by robust data from the ongoing DESTINY-PanTumor02 Phase II trial, which has demonstrated its clinical benefits in patients with HER2-expressing metastatic solid tumors. The inclusion of data from other supporting trials further strengthens the application’s case for approval.

Enhertu’s FDA Priority Review: A Transformative Breakthrough in HER2-Positive Cancer Treatment

The FDA’s Priority Review process is designed to expedite the approval of medicines that offer significant improvements over existing treatments. In the case of Enhertu, the potential to provide a tumor-agnostic therapy for HER2-positive solid tumors represents a substantial advancement in the field of oncology. The acceptance of the sBLA for Priority Review is a promising development for patients with HER2-positive solid tumors who have limited treatment options. It reflects the commitment of AstraZeneca and Daiichi Sankyo to advancing cancer care and providing innovative solutions for patients facing challenging diagnoses.

The Priority Review granted to Enhertu underscores its potential to redefine the treatment landscape for HER2-expressing cancers. If approved, it will mark a significant milestone in personalized cancer therapy, offering new hope for patients with limited treatment options. The sBLA for Enhertu is currently under review as part of the FDA’s Real-Time Oncology Review and Project Orbis initiatives. These programs aim to accelerate the availability of effective cancer treatments to patients, emphasizing the importance of timely access to innovative therapies.

 

Resource: AstraZeneca, January 29, 2024

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