August 09, 2021
Methodist Children’s Hospital is proud to announce its efforts to advance the clinical research of childhood cancer have contributed to the recent Food and Drug Administration (FDA) approval of a new and much-needed drug for children and adults diagnosed with leukemia. June 30, 2021, the FDA approved Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), a drug to be used during chemotherapy treatment. Methodist Children’s Hospital was the first site in the country to enroll a pediatric patient in the drug’s clinical research trial. According to the FDA, the drug’s efficacy was studied in 102 patients, six of which are patients of Methodist Children’s Hospital.
The FDA says an estimated 20 percent of leukemia patients are allergic to a component in the standard chemotherapy regimen. The only other FDA-approved drug for patients with allergic reactions has been in a global shortage since 2016.
“This is a great advancement for the treatment of leukemia,” said Vinod K. Gidvani-Diaz, MD, principal investigator at Methodist Children’s Hospital. “Prior to the approval of this medication, patients who were allergic to the frontline drug had limited options since the alternative medication was not widely available. Some patients ended up missing this very important part of the treatment. Now that this new medication has been approved by the FDA, we will have a widely available alternative that has been proven to be efficacious and well tolerated.”
Methodist Children’s Hospital is part of the Children’s Oncology Group (COG), a National Cancer Institute clinical trials group. It is the world’s largest organization devoted exclusively to childhood and adolescent cancer research.
“There aren’t a lot of treatment guidelines for children with cancer,” said Dr. Gidvani-Diaz. “We try to identify a clinical trial to offer to every patient. Their participation is voluntary. Many trials, such as this one, provide investigational drugs not labeled by the FDA for pediatric patients.”
The COG has nearly 100 active clinical trials open at any given time. According to the National Cancer Institute, COG research has turned children’s cancer from a virtually incurable disease 50 years ago, to one with a combined five-year survival rate of 80 percent today.
Learn more about the FDA approval visit on the FDA's website