FDA Grants Breakthrough Device Designation to Software as a Medical Device for AML

Based on positive preliminary efficacy findings, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to software as a medical device (SaMD) BNT200 for the treatment of anxiety and depression in hospitalized adults with acute myeloid leukemia (AML) undergoing high-intensity induction chemotherapy.

BNT200, a prescription-only digital therapeutic, is intended for use in the inpatient setting over a 4- to 6-week period in conjunction with a high-intensity induction chemotherapy regimen. The content is synchronized with chemotherapy to moderate the psychological stressors endured by this subset of patients with AML and is therefore not applicable to patients with AML undergoing outpatient treatment.

“For the thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult,” said Areej El-Jawahri, MD, Associate Director of the Cancer Outcomes Research and Education Program at Massachusetts General Hospital and principal investigator of the clinical study evaluating BNT200. “The advancement of innovative therapeutic options for the treatment of the associated distress that often follows a diagnosis is promising for patients and addresses an unmet need.”

Source: Blue Note Therapeutics press release, January 6, 2022.