FDA Approval Of Cancer Drug Gives Hope For Childhood Leukemia Cure

The U.S. Food and Drug Administration has given approval to a new drug, Rylaze, which, in all probability will help solve a major concern in the treatment of children suffering from acute lymphoblastic leukemia or ALL.

Most children are known to develop an allergy to one of the key components of the treatment process.

Research shows that around 15 percent of children with ALL develop an allergic or any other immune reaction to the drug, Pegaspargase, mostly used in chemotherapy. Pegaspargase is the most widely used form of a drug known as asparaginase, which is one of the main parts of all treatments for ALL.

According to doctors, a substitute for the drug, Erwinia asparaginase or Erwinaze can be administered if the patient develops an allergy but there is a global shortage of this alternate drug. That has been attributed to manufacturing issues.

The issues related to the allergic reaction and the shortage of an alternative drug were accelerated when recent studies, including a Children's Oncology Group or COG study led by Dr Sumit Gupta, a pediatric oncologist at the Hospital for Sick Children in Toronto, revealed that children who do not get a full course of asparaginase are at high risk of their cancer relapsing.

On June 30, the FDA gave approval to a new version of asparaginase, erwinia chrysanthemi (recombinant)-rywn or Rylaze, which was mainly developed to overcome the shortages of Erwinia asparaginase. Rylaze was approved as part of the treatment regimen for children and adults with ALL or lymphoblastic lymphoma or LBL, a rare but aggressive cancer, similar to ALL.

Commenting on the developments, Malcolm Smith of NCI's Cancer Therapy Evaluation Program said, "Rylaze has the same molecular makeup as Erwinaze. But it's manufactured differently, and in a more efficient way, so having the option to substitute Rylaze should reduce the likelihood of treatment shortages for these patients in the future."

The FDA approval of Rylaze was based on studies done on 102 children and adults with ALL or LBL who were allergic to E. coli asparaginase or experienced silent inactivation. These patients were part of a clinical trial to understand the new drug's safety and if it can achieve certain levels of asparaginase activity in the blood, said Rachel Rau, MD, Baylor College of Medicine, who was part of the study.

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