Jazz Pharmaceuticals’ Leukemia and Lymphoma Drug Wins FDA Approval
The FDA has approved Jazz Pharmaceuticals’ Rylaze as part of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoma.
The drug, asparaginase erwinia chrysanthemi (recombinant)-rywn, is meant for patients who are allergic to the E. coli-derived asparaginase products generally used in treatment of the cancers.
And the drug’s approval could provide a “consistently sourced alternative” for a crucial component of the chemotherapy regimen that is often in short supply, said Gregory Reaman, associate director for pediatric oncology in the FDA’s Oncology Center of Excellence.
The approval was supported by a study of 102 patients that showed the drug induced a positive response in 94 percent of patients.