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Formal Report Issued to FDA on Chemotherapy-Induced Hearing Loss in Pediatrics

Childhood cancer survivors and caregivers shared experiences with social isolation, anxiety and fear caused by hearing loss from platinum-based treatment during workshop hosted by Children's Cause, CBTF, Mattie Miracle, and Momcology.


News provided by

Children’s Cause for Cancer Advocacy

May 30, 2019, 15:00 ET

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WASHINGTON, May 30, 2019 /PRNewswire-PRWeb/ -- Organizers of a workshop on chemotherapy-induced hearing loss in pediatrics issued a formal Voice of the Patient report to the Food and Drug Administration (FDA) this week. Young adult survivors of childhood cancer and parents of children with cancer participated in this externally-led Patient Focused Drug Development meeting on September 13, 2018, in the DC metro area.

"This meeting was an incredibly empowering day for childhood cancer survivors and family members, giving them a long-deserved spotlight to share their very personal stories about the severe impact that hearing loss has had on their lives," said George Dahlman, Chief Executive Officer of the Children's Cause for Cancer Advocacy. "The formal report provides the FDA with patient perspectives to inform their regulatory decision-making and improve the drug development process. It is our hope that this report will be used to guide approvals of much-needed therapies to prevent - and ultimately treat - chemotherapy-induced hearing loss in survivors of childhood cancer."

It is our hope that this report will be used to guide approvals of much-needed therapies to prevent - and ultimately treat - chemotherapy-induced hearing loss in survivors of childhood cancer.

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The pediatric patient population with chemotherapy-induced hearing loss represents a segment of the cancer survivor community with a severe burden of disease with great unmet medical and psychosocial need. In the U.S., approximately 5,000 children with cancer receive platinum-based chemotherapy such as cisplatin and carboplatin as their first or second line treatment annually. Approximately 50-60% of children treated with cisplatin and 5-20% of those treated with carboplatin acquire some degree of irreversible hearing loss.

This workshop brought together - in person and via live webcast - approximately 250 survivors, caregivers, FDA representatives, medical professionals and pharmaceutical representatives to explore this condition further with the goal of better understanding the non-medical impact that current medical treatments cause, and the need to do better for children with cancer.

The agenda featured a series of facilitated panel and audience discussions, and a webinar with live polling focused on providing the FDA and other stakeholders with patient views on burden of the condition, current and potential future treatments, a risk-benefit assessment, and clinical trials.

The report can be found in its entirety at childhoodcancerpfdd.org.

Among the key points in the report:

  • Survivors with hearing loss report severe social isolation and anxiety as their single most challenging quality-of-life issue, describing difficulties in trying to keep up at school or interact with colleagues at work.
  • Although patients use a variety of devices, therapies, and adaptation strategies to manage the consequences of hearing loss, the effectiveness is limited and each modality has significant downsides, with 37% of respondents indicating that these interventions did not help at all.
  • Hearing aids are the most widely-used intervention but can have significant disadvantages, including discomfort, expense, reliance on battery life, and poor performance in noisy environments.
  • The number one issue that worries caregivers and patients the most about hearing loss is that its severity will worsen, impacting related issues like tinnitus and balance.

This FDA-approved, externally-led meeting was organized and presented by the following national childhood cancer organizations: Children's Cause for Cancer Advocacy; Children's Brain Tumor Foundation; Mattie Miracle Cancer Foundation; and Momcology.

This workshop was made possible through generous sponsorships from Decibel Therapeutics, Fennec Pharma, Frequency Therapeutics, Novartis, Otonomy, Sensorion, and Spiral Therapeutics.

SOURCE Children’s Cause for Cancer Advocacy

Related Links

https://www.childhoodcancerpfdd.org/

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