FDA Grants Breakthrough Therapy Designation to Device to Treat AML-Induced Depression

The FDA has granted a breakthrough device designation to BNT200, a digital therapeutic designed to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) currently hospitalized for a regimen of high-intensity induction chemotherapy, according to a press release by Blue Note Therapeutics.

BNT200 is a software that is designed to treat the unique psychological stressors that create anxiety and depressive symptoms in adult patients with AML undergoing high-intensity induction chemotherapy. It is an on-demand digital therapeutic, with content synchronized with high-intensity chemotherapy treatment. Due to its design, BNT200 is not meant to be used by patients with AML in the outpatient setting.

"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, the principal investigator whose research team is leading the clinical study to evaluate the impact of BNT200 on quality of life, mood, and symptoms of patients diagnosed with AML in a press release. "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."

Nearly half of all patients with cancer experience psychological distress, depression, or anxiety, according to the press release. These feelings can lower quality of life and may negativity affect survival if left untreated. Despite National Comprehensive Cancer Network guidelines for the delivery of mental health care services in oncology, which includes implementing a treatment plan for patients experiencing distress to meet with a mental health care specialist, fewer than half of patients experiencing cancer-related stress meeting with a mental health care specialist. BNT200 is designed to help close that treatment gap, the company added.

“Patients hospitalized after their AML diagnosis often experience a sudden disruption of their life with substantial physical and psychological impacts," said Geoffrey Eich, CEO of Blue Note Therapeutics, in a press release. "We are pleased that the FDA has recognized the need to speed up development and review of BNT200, as well as encouraged by our ability to help reduce the symptoms of distress and improve quality of life and care in patients newly diagnosed with AML."

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_{Blue Note Therapeutics receives breakthrough device designation for prescription-only digital therapeutic for acute myeloid leukemia. News release. Blue Note Therapeutics. January 6, 2022. Accessed January 10, 2022.}