ENHERTU has been on the market for 2 years, 1 month, and 7 days as of June 11, 2024, following its initial FDA approval on May 4, 2022.
ENHERTU (trastuzumab deruxtecan) first became available after receiving U.S. Food and Drug Administration (FDA) approval. Since its initial clearance, its market presence has expanded through subsequent approvals for various indications in breast cancer treatment.
Key Milestones in ENHERTU's Market Journey
ENHERTU has achieved significant approvals that have broadened its application and availability in the oncology landscape.
| Approval Date | Indication |
|---|---|
| May 4, 2022 | Approved for patients who had only received one prior treatment for HER2-positive breast cancer. |
| August 2022 | Cleared for the treatment of HER2-low breast cancer in patients who had already received chemotherapy treatment. |
The earliest date ENHERTU officially entered the U.S. market was May 4, 2022. On this date, the FDA granted its first approval for use in patients with HER2-positive breast cancer who had previously undergone only one treatment. This marked a crucial step in making the drug accessible to a specific patient population.
Building on this initial success, the FDA further expanded ENHERTU's scope in August 2022. This subsequent approval allowed its use for treating HER2-low breast cancer in patients who had already received chemotherapy. This extension underscores the drug's versatility and its growing role in addressing different categories of breast cancer, demonstrating its continued impact on the market since its launch.
