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A few days ago, Rylaze, an oncology drug from Jazz Pharmaceuticals, was approved by the US FDA for the treatment of pediatric patients 1 month and older who are allergic to E.
Approximately 5,700 patients develop ALL in the United States each year, and about half of them are children
Rylaze was approved based on partial data from the Phase II trial of the Phase II/III study, which evaluated different dosing regimens of the drug
The drug was designated by the FDA as a rare disease drug for the treatment of ALL/LBL in June 2021
The drug was evaluated in a trial of 102 patients who were allergic or silently inactivated to E.
The most common adverse reactions of the drug include hypersensitivity, pancreatic toxicity, thrombosis, bleeding, and liver toxicity
After approval, Jazz said it will continue to cooperate with the FDA and will submit additional data for the complete patient cohort to evaluate Rylaze intramuscular administration and other administration measures
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