CAC2 Webinar–Hearing Loss from Cisplatin—Multiple Perspectives on the New FDA Preventative Treatment Option

Children who receive cisplatin as part of their cancer treatment are at risk for progressive and/or permanent hearing loss as a result of their treatment.  This treatment effect can influence speech and language development, educational achievement, and social-emotional development.  Recently, the FDA approved Pedmark, a Sodium Thiosulfate Injection created by Fennec Pharmaceuticals, as a treatment to help reduce the risk of ototoxicity associated with cisplatin.  November’s CAC2 All-Member webinar provided key information about this important breakthrough in improving the quality of life for childhood cancer survivors who received cisplatin. Attendees learned about the importance of this specific drug approval, the [...] Read more

CAC2 Childhood Cancer Community News Digest (November 21-27)

Assorted News from the Last Week: CAC2 Member Mary Beth Collins explains the importance of the new FDA approval of Pedmark:  "With the FDA’s recent approval of Pedmark (an injectable formulation of sodium thiosulfate ("STS"), children are protected from cisplatin’s ototoxicity.  This development is substantial for children in treatment because it maintains their hearing, providing a better quality of life." Hayley Arceneaux became the youngest American to go to space last year after she spent three days in orbit on Space-X's Inspiration rocket. She is telling her story in a new book. Pediatric patients who receive central nervous system (CNS)-directed treatment for [...] Read more

Survivorship Matters Blog: Pedmark – Improving Quality of Life for Childhood Cancer Survivors Preventing Chemo-Induced Hearing Loss

Survivorship Matters Blog By CAC2 Individual Member Mary Beth Collins “Your child has to be alive to experience side effects” It is heard by every parent of a child with a high-risk pediatric cancer when reviewing treatment protocol: your child must endure and survive all of the therapies first, before a parent can afford to be concerned about side effects.  It’s a pragmatic priority; the focus is on keeping your child alive and achieving No Evidence of Disease, or ”NED” as commonly referenced.  With the most challenging cancers, it is spoken with earnest and delicate honesty. Today, according to the […]

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CAC2 Childhood Cancer Community News Digest (November 14-20)

Assorted News from the Last Week: CAC2 Member Joe Baber reflects on the Gabriella Miller Kids First 2.0 legislation pending in Congress:  "We’re all thankful when there are lifesaving therapies and at the very same time, we are fearful of relapse, side effects of the drugs, chemotherapy, radiation, surgery and even death.  These contrary and parallel emotions seem to be linked in partnership throughout the childhood cancer experience." This month, Dr. Gregory Reaman was named by the Childhood Cancer Data Initiative (CCDI) as the new Scientific Director. In this role, Dr. Reaman will develop, direct, and coordinate CCDI programs and [...] Read more

Thankful and Fearful

By CAC2 Individual Member Joe Baber Because of my grandson, Conor, a neuroblastoma survivor, I have met so many people in our childhood cancer community who want to improve the outcomes of children fighting cancer. We either have children in treatment for cancer or have children who are survivors or have died because of it.  We’re all thankful when there are lifesaving therapies and at the very same time, we are fearful of relapse, side effects of the drugs, chemotherapy, radiation, surgery and even death.  These contrary and parallel emotions seem to be linked in partnership throughout the childhood cancer […]

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Childhood Cancer Data Initiative Welcomes Dr. Gregory Reaman as Its New Scientific Director

This month, Dr. Gregory Reaman was named by the Childhood Cancer Data Initiative (CCDI) as the new Scientific Director. In this role, Dr. Reaman will develop, direct, and coordinate CCDI programs and initiatives, as well as provide scientific oversight and recommendations to drive CCDI’s vision and progress. He comes to NCI most recently from the US Food and Drug Administration, with a career dedicated to caring for children with cancer and decades of leadership experience improving childhood cancer research. The CCDI team isn’t the only part of CCDI that expanded. NCI released initial data from the CCDI Molecular Characterization Initiative, [...] Read more

CAC2 Childhood Cancer Community News Digest (November 7-13)

Assorted News from the Last Week: The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC) in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.  Read more:  Administration of a targeted therapy for children with high-risk Hodgkin lymphoma (HL) was found to significantly decrease relapse rates in a large multicenter clinical trial conducted by the Children’s Oncology Group (COG) and published in The New England Journal of Medicine. Researchers have used CRISPR/Cas9 technology to engineer donor T cells to try to treat seriously ill children with resistant [...] Read more

The Fit for Filing Group at ACCELERATE

Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group   The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies.   The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are: Define the barriers and propose solutions to ensure […]

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CAC2 Childhood Cancer Community News Digest (October 31-November 6)

Assorted News from the Last Week: November is National Family Caregivers Month.  The President Joe Biden honored family caregivers for all they do for the nation with a Presidential Proclamation. "No one should have to choose between a paycheck and looking after a loved one. My Administration is committed to easing that squeeze on working families and getting caregivers the resources and respect they deserve. The Department of Health and Human Services’ National Strategy to Support Family Caregivers outlines nearly 350 actions the Federal Government can take to support family caregivers’ health, well-being, and financial security. Our American Rescue Plan [...] Read more

Guest Blog–New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.  “Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who can’t provide consent for themselves and are afforded additional safeguards when participating in […]

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