FDA clears digital app to help cancer patients self-manage their symptoms

Digital therapeutic developer Voluntis received a marketing authorization from the FDA for what it describes as the first software-as-a-medical-device cleared for use in all different types of cancer—a program previously dumped by Roche’s French pharma division.

The company’s Oleena mobile app and its algorithms are designed to provide users with real-time, adaptive recommendations to help them manage their own symptoms on a day-to-day basis.

Combined with remote patient monitoring and care team support, it aims to help them avoid the distressing yet common events and side effects that may lead to interruptions in their treatment—such as pain, diarrhea and nausea—as well as those that hinder daily function and quality of life. Voluntis also hopes it will help reduce unnecessary emergency room visits and hospitalizations.

The prescription app was branded a Class II medical device by the FDA; in addition to personalized coaching, it also supplies on-demand directions for initiation and dosing of supportive therapies based on a patient’s previously set care plan, according to Voluntis.

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“Beyond monitoring their symptoms, we believe that empowering patients via the digital delivery of real-time and personalized therapeutic interventions offers the opportunity for significant clinical and economic outcomes,” CEO Pierre Leurent said in a statement.

Oleena is designed to help guide patients through a range of diagnoses as well as different anticancer treatments such as chemotherapy, immunotherapy and targeted therapies including PARP, PI3K and CDK4/6 inhibitors.

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Voluntis previously signed a development deal with Roche Pharma France on a similar product focused on breast cancer, featuring a mobile app that analyzes symptoms and makes personalized care recommendations with the goal of improving adherence.

First launched in October 2015, the collaboration was formally ended earlier this year after Roche decided to not pursue further development of the app, known as Zemy, nor additional plans to extend its use to other solid tumors.