St. Baldrick’s Foundation Plays Key Role in FDA Approved Childhood Cancer Drug

Unituxin is approved for first-line treatment of patients with high-risk neuroblastoma

LOS ANGELES (March 11, 2015) – The St. Baldrick’s Foundation, the largest non-government funder of childhood cancer research grants, applauds the U.S. Food and Drug Administration’s (FDA) approval of Unituxin (dinutuximab), a groundbreaking therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children. This immunotherapy treatment is the result of 20 years of work spearheaded by Alice Yu, M.D., Ph.D., University of California San Diego, principal investigator of the registration study for Unituxin conducted by the Children’s Oncology Group (COG).

St. Baldrick’s has taken a strong stance at being in the forefront of funding research for new drugs. The Foundation has granted more than $100,000 directly to Dr. Yu, more than $1.2 million for a consortium of institutions working on related neuroblastoma research, and more than $53 million since 2005 to the Children’s Oncology Group for clinical trials, including the trials that led to this drug becoming available for high-risk neuroblastoma patients.

“The research that led to Unituxin’s FDA approval was decades in the making, and the St. Baldrick’s Foundation helped to make it possible with their funding of my work,” said Dr. Yu. “All of the support and the collaboration surrounding finally making this treatment available is testament to the power of what we as individuals can do when working together.”

While Unituxin was initially manufactured by the National Cancer Institute (NCI), it’s now being produced by United Therapeutics Corporation because of the Creating Hope Act and has now become one of the few drugs in history to receive FDA approval specifically for a childhood cancer. Through the St. Baldrick’s advocacy program, St. Baldrick’s volunteers played a key role in the passage of the Creating Hope Act, which provides market incentives to pharmaceutical companies to develop drugs for pediatric rare diseases, including pediatric cancers.

“Through our collaborative channels, support of virtually every phase of research, support of clinical trials and advocacy for important legislation like the Creating Hope Act, we’re leading the way to breakthroughs in treatments like the one we were able to fund for Dr. Yu and Unituxin,” said Kathleen Ruddy, CEO of the St. Baldrick’s Foundation. “Thanks to our many volunteers and our generous donors, we’ve done a lot, and yet, cancer remains the most common cause of death by disease for children. We must do more. And St. Baldrick’s is doing that with its advocacy program that empowers individuals to speak up and take action in ways that together will help fund more research and find more cures.”

This news comes at a time when more than 31,000 volunteers have registered to brave the shave at more than 1,000 St. Baldrick’s signature head-shaving events taking place around the globe this year.

About St. Baldrick’s Foundation
The St. Baldrick’s Foundation is a volunteer-driven charity committed to funding the most promising research to find cures for childhood cancers and give survivors long and healthy lives. St. Baldrick’s coordinates its signature head-shaving events worldwide where participants collect pledges to shave their heads in solidarity with kids with cancer, raising money to fund research. Since 2005, St. Baldrick’s has awarded more than $154 million to support lifesaving research, making the Foundation the largest private funder of childhood cancer research grants. St. Baldrick’s funds are granted to some of the most brilliant childhood cancer research experts in the world and to younger professionals who will be the experts of tomorrow. Funds awarded also enable hundreds of local institutions to participate in national pediatric cancer clinical trials, and the new International Scholar grants train researchers to work in developing countries. For more information about the St. Baldrick’s Foundation please call 1.888.899.BALD or visit www.StBaldricks.org.

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