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The June 30 approval meets an unmet need in this cancer.
Jazz Pharmaceuticals has announced that the National Comprehensive Cancer Network (NCCN) added Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology for acute lymphoblastic leukemia (ALL), for both pediatric and adult patients.
Jazz Pharmaceuticals launched Rylaze on July 21, just three weeks after the drug was approved by the FDA. The approval followed review of a biologics license application (BLA) under the FDA’s Real-Time Oncology Review program, and it was based on clinical data from a pivotal phase 2/3 trial conducted in collaboration with the Children’s Oncology Group.
“Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from E. coli are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients,” Rob Iannone, M.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals, said in a statement. “Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence.”
The only other FDA-approved drug for such patients with allergic reactions has been under global shortage since 2016. Jazz Pharmaceuticals’ Erwinaze (asparaginase erwinia chrysanthemi) has experienced supply and manufacturing issues from the owner and manufacturer of the product, Porton Biopharma Limited. Jazz Pharmaceuticals’ agreement with Porton Biopharma ended in December 2020.