FDA Grants Breakthrough Device Designation to BNT200 for Anxiety/Depression in AML

The FDA has granted a breakthrough device designation to BNT200, a prescription-only digital therapeutic to leverage in the treatment of anxiety and depressive symptoms created by psychological stressors experienced by adults with acute myeloid leukemia (AML) who are hospitalized and undergoing high-intensity induction (HIC) chemotherapy.¹

The device was developed for use in the inpatient setting during the 4 to 6 weeks in which HIC treatment is administered. The content is synchronized with the HIC regimen to dull the stressors endured by this unique patient population. As such, BNT200 is not applicable for use in those with AML who are undergoing outpatient treatment.

This designation is awarded to novel medical devices that possess the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The application for BNT200 was supported by data demonstrating the device’s usability and preliminary efficacy.

“For thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult,” Areej El-Jawahri, MD, associate director of the Cancer Outcomes Research and Education Program, director of the Bone Marrow Transplant Survivorship Program, and associate professor of medicine at Massachusetts General Hospital, stated 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.”

El-Jawahri also serves as the principal investigator of a trial that is evaluating the impact of the device on quality of life (QoL), mood, and symptoms of patients diagnosed with AML.

To date, approximately 18 million patients with cancer and survivors reside in the United States and half of these individuals are known to experience psychosocial distress, anxiety, or depression.² If these symptoms are not treated, QoL can suffer, and survival can be negatively impacted.

Although the National Comprehensive Cancer Network has produced guidelines for the delivery of mental health care services in the cancer realm, which include screening for signs of distress and implementing treatment plans to address existing needs with a mental health specialist, fewer than 50% of these individuals are referred to such professionals. To address this need, prescription digital therapeutics have been developed.

“Patients hospitalized after diagnosis with AML often experience a sudden disruption of their life with substantial physical and psychological impacts,” Geoffrey Eich, chief executive officer of Blue Note Therapeutics, added in the 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 QoL and care in patients with newly diagnosed AML.”

References

1. Blue Note Therapeutics receives breakthrough device designation for prescription-only digital therapeutic for acute myeloid leukemia. News release. Blue Note Therapeutics; January 2022. Accessed January 11, 2022. https://bit.ly/3qieSNN
2. Cancer-related distress. Blue Note Therapeutics website. Accessed January 11, 2022. https://bit.ly/3ty9R5N