Announced details
Acute leukemia with a relapsed or refractory KMT2A gene rearrangement. A trial is also being conducted in relapsed or refractory acute myeloid leukemia with an NPM1 gene mutation.
The U.S. subsidiary Sumitomo Pharma America, Inc. received the designation from the FDA.
The U.S. drug regulatory authority. The agency oversees drug development and review, including Breakthrough Therapy designations.
FDA Breakthrough Therapy designation
U.S. Food and Drug Administration (FDA)
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
| Item | Details |
|---|---|
| Names of Products / Services Covered | enzomenib, DSP-5336 |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The U.S. drug regulatory authority. The agency oversees drug development and review, including Breakthrough Therapy designations. |
| Relationship with the Company | The U.S. subsidiary Sumitomo Pharma America, Inc. received the designation from the FDA. |
| Applicable area | Acute leukemia with a relapsed or refractory KMT2A gene rearrangement. A trial is also being conducted in relapsed or refractory acute myeloid leukemia with an NPM1 gene mutation. |
| Award/certification name | FDA Breakthrough Therapy designation |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
Items this document does not state (11)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Because it targets serious or life-threatening diseases and clinical trial data indicated the potential for substantial improvement on clinically significant endpoints over existing treatments.