Blue Note leukaemia DTx gets FDA breakthrough tag

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA.

The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy.

Breakthrough designations can speed up the development of new therapies, making them available to patients sooner. It is well-established for conventional drugs and medical devices but has only recently started to be used for DTx.

Last year, Biofourmis said its heart failure tool BiovitalsHF was the first DTx to be awarded breakthrough status by the FDA.

It has since been joined by other products in the software as a medical device (SaaMD) category, including Pear Therapeutics' alcohol-use disorder candidate Pear-009 and another Blue Note DTx, codenamed BNT001, which is also being tested for anxiety and depression in cancer patients.

Blue Note said the new status recognised the potential of BNT200 for the thousands of patients diagnosed with AML every year in the US who can find it challenging to cope with both the symptoms of the cancer and the debilitating side effects of treatment.

The DTx is an on-demand stress management intervention with content synchronised with high-intensity chemotherapy treatment. According to Blue Note it is intended "to blunt the unique psychological stressors endured by this subset of patients with AML". It isn't intended for AML patients treated as outpatients.

"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," said Areej El-Jawahri of Massachusetts General Hospital.

He is the principal investigator for a clinical study that will evaluate the impact of BNT200 on quality of life, mood, and symptoms of patients diagnosed with AML.

BNT200 and BNT100 are among a series of therapies that Blue Note is developing for specific cancer settings.

In 2020, it formed an alliance with Memorial Sloan Kettering Cancer Centre in the US to develop an app that can be used by patients who are living in fear of their cancer, for example. Other DTxs are aimed at people being treated for breast and lung cancers.