FDA Grants Breakthrough Device Designation for BNT200 in Acute Myeloid Leukemia

The FDA has granted breakthrough device designation for BNT200, a prescription only, digital therapeutic that helps to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) who have been hospitalized from high-intensity induction chemotherapy, according to a press release from Blue Note Therapeutics.¹

BNT200 was designed to treat anxiety and depressive symptoms that occur during high-intensity induction chemotherapy for patients with AML. The on-demand software as a medical device is intended for use in the in-patient setting throughout the 4- to 6-week period often associated with high-intensity chemotherapy. As the device aims to lessen the psychological stressors associated with high-intensity induction chemotherapy, it will not be available for those in the outpatient setting.

"Patients hospitalized after diagnosis with AML often experience a sudden disruption of their life with substantial physical and psychological impacts. 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 [with] newly diagnosed with AML," Geoffrey Eich, CEO of Blue Note Therapeutics, said in the press release.

Guidelines have been established by the National Comprehensive Cancer Network (NCCN) on the delivery of mental health care services for patients who are experiencing cancer-related distress.² This includes screening for signs of distress and implementing a treatment plan in accordance with a mental health specialist. Cancer-related distress can be described as an unpleasant feeling, emotion, or experience that affects a patient’s quality of life or ability to cope with the diagnosis and treatment. Patients who experience such feelings are typically referred to a mental health professional.

Additionally, the NCCN recommends screenings in order to determine a patient’s mental health needs and establish an appropriate treatment plan, referring the patient for psychosocial care as needed. Strategies should be reevaluated and adjusted appropriately. Distress ought to be diagnosed and treated quickly across all stages and settings in addition to determining the level and nature of the distress. Distress screenings should take place during every medical visit, determining baseline levels during the initial visit and checking in at appropriate intervals, especially in accordance with changes in disease such as remission, recurrence, and progression. Notably, the guidelines highlighted the need for interdisciplinary institutional committees comprised of physicians, nurses, and psychologists in order to implement distress management standards. Furthermore, in order to implement standard, institutions should rely on mandatory support from leadership, develop a pilot program prior to large-scale implementation, and consider current resources and workflow.

Educational platforms and appropriate training should be established for clinicians in order to better help with the assessment and management of distress, the guidelines stated. Moreover, licensed mental health professionals and spiritual leaders such as chaplains with experience in psychosocial care should also be available, either as staff or via referral. The guidelines also recommend that clinical health outcome measurements should include psychosocial wellbeing as a domain. Patients’ support systems including their family and treatment team should also be made aware that distress management is an important part of cancer care and should be equipped with information on mental health care services both within the treatment center and community.

Although the guidelines are broad, management of distress should be tailored to each patient to fit their needs.

Novel medical devices are granted a breakthrough device designation if they may provide effective treatment or diagnosis of life-threatening or debilitating conditions. BNT200’s breakthrough device designation was supported via positive usability and preliminary efficacy findings.

“For the thousands of patients diagnosed with AML each year, managing and coping with disease symptoms can be especially difficult. 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,” principal investigator Areej El-Jawahri, MD, associate director of cancer outcomes research and education program, director of the Bone Marrow Transplant Survivorship Program, and an associate professor of medicine at Massachusetts General Hospital, concluded.

References

1. Blue Note Therapeutics receives breakthrough device designation for prescription-only digital therapeutics for acute myeloid leukemia. News Release. January 6, 2022. Accessed January 25, 2022. https://yhoo.it/342KpKO

2. Riba MB, Donovan KA, Andersen B, et al. Distress management, Version 3.2019, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2019;17(10):1229-1249. doi:10.6004/jnccn.2019.0048