What's Happening?
The European Medicines Agency (EMA) has initiated a review of Enhertu, a drug developed by Daiichi Sankyo and AstraZeneca, for use as a first-line therapy in patients with HER2-positive breast cancer.
This review follows the submission of Enhertu (trastuzumab deruxtecan) for approval in combination with pertuzumab for patients newly diagnosed with unresectable or metastatic HER2-positive breast cancer. The submission is based on the results of the DESTINY-Breast09 study, which demonstrated a 44% reduction in the risk of disease recurrence or death compared to the current standard of care. Enhertu is already approved for this indication in the United States, and the companies aim to expand its use in Europe. The drug has shown significant promise, with revenues reaching $3.58 billion in the first half of the year, marking a 31% increase from the previous year.
Why It's Important?
The review of Enhertu by the EMA is significant as it could lead to the approval of a new first-line treatment option for HER2-positive breast cancer, a condition that affects 15% to 20% of patients with advanced-stage disease. Current treatments have limited effectiveness, with many patients experiencing disease progression within two years. Enhertu's approval could improve outcomes for these patients, offering a new hope for those with aggressive forms of breast cancer. Additionally, the potential approval aligns with AstraZeneca's strategy to increase its sales to over $80 billion by 2030, with Enhertu playing a crucial role in this growth. The drug's success could also pave the way for its use in earlier stages of breast cancer treatment, further expanding its market potential.
What's Next?
If the EMA approves Enhertu for first-line use, it could become a standard treatment option for HER2-positive breast cancer in Europe, potentially improving survival rates and quality of life for patients. Daiichi Sankyo and AstraZeneca are also preparing to file for the drug's use in perioperative settings, based on ongoing studies. These developments could further solidify Enhertu's position in the oncology market and contribute to its projected $5 billion annual sales target. The companies will likely continue to invest in clinical trials to explore additional indications and expand the drug's use in other cancer types.
