WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted by the U.S. Food and Drug Administration (FDA) for Priority Review. This review is for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have previously undergone endocrine therapy.
The Priority Review is based on the results of the DESTINY-Breast06 Phase III trial, which showed a statistically significant and clinically meaningful progression-free survival benefit of ENHERTU compared to chemotherapy. The trial's findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
The FDA grants Priority Review to therapies that could provide significant improvements over existing options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The anticipated FDA action date for their regulatory decision is expected in the first quarter of 2025.
ENHERTU has also been granted Breakthrough Therapy Designation (BTD) by the FDA for this patient population, which accelerates the development and regulatory review of new medicines intended to treat a serious condition and address a significant unmet medical need.
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, noted that the results from DESTINY-Breast06 could potentially evolve the treatment landscape for HR-positive metastatic breast cancer, offering a targeted treatment for patients with HER2-low or HER2-ultralow expression following endocrine therapy.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, emphasized the potential to expand the indication of ENHERTU to include use in an earlier disease setting and a broader patient population.
In the DESTINY-Breast06 trial, ENHERTU reduced the risk of disease progression or death by 37% compared to chemotherapy. The median progression-free survival (PFS) was 13.2 months with ENHERTU versus 8.1 months with chemotherapy. The safety profile was consistent with previous clinical trials, with no new safety concerns identified.
ENHERTU is a HER2-directed antibody drug conjugate (ADC) developed by Daiichi Sankyo and is already approved in more than 65 countries, including the U.S., for patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
This information is based on a press release statement.
In other recent news, AstraZeneca has experienced a series of developments. The pharmaceutical giant's drug, TAGRISSO, received U.S. Food and Drug Administration (FDA) approval for the treatment of Stage III epidermal growth factor receptor-mutated non-small cell lung cancer. The approval was based on the LAURA Phase III trial, which showed a significant reduction in the risk of disease progression or death.
In addition, the FDA approved AstraZeneca's FluMist influenza vaccine for self-administration at home, potentially increasing vaccination rates. The company's Fasenra also gained FDA approval for the treatment of adult patients with a rare immune-mediated vasculitis, eosinophilic granulomatosis with polyangiitis.
However, AstraZeneca faced challenges with two of its potential drugs failing to demonstrate effectiveness in treating lung and breast cancer. These setbacks led to Erste Group revising its rating for AstraZeneca from Buy to Hold. Despite this, Deutsche Bank (ETR:DBKGn), BMO (TSX:BMO) Capital, TD (TSX:TD) Cowen, and BofA Securities maintained positive outlooks on AstraZeneca shares. These developments reflect the ongoing advancements and challenges at AstraZeneca.
InvestingPro Insights
AstraZeneca's recent FDA acceptance for Priority Review of ENHERTU® aligns with the company's strong market position and growth prospects. According to InvestingPro data, AstraZeneca boasts a substantial market capitalization of $241.71 billion, reflecting its status as a major player in the pharmaceutical industry.
The company's revenue growth of 10.45% over the last twelve months and 13.33% in the most recent quarter underscores its ability to expand its market presence, likely driven by successful drug developments like ENHERTU®. This growth trajectory is further supported by an InvestingPro Tip indicating that net income is expected to grow this year.
AstraZeneca's commitment to innovation and pipeline development is reflected in its high P/E ratio of 37.4, suggesting investors are willing to pay a premium for future growth potential. This aligns with another InvestingPro Tip highlighting that the company is trading at a high earnings multiple, which may be justified by breakthroughs like the potential expansion of ENHERTU®'s indications.
For investors seeking more comprehensive analysis, InvestingPro offers 13 additional tips for AstraZeneca, providing deeper insights into the company's financial health and market position.
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