FDA Approves Jazz's Rylaze To Treat Acute Lymphoblastic Leukemia Or Lymphoblastic Lymphoma

Jazz Pharmaceuticals plc (JAZZ) said that the U.S. Food and Drug Administration has approved Rylaze--asparaginase erwinia chrysanthemi (recombinant)-rywn--for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia or ALL or lymphoblastic lymphoma or LBL in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase.

The company expects Rylaze will be commercially available in mid-July.

Rylaze was granted orphan drug designation for the treatment of ALL/LBL by FDA in June 2021. The Biologics Licensing Application approval followed review under the Real-Time Oncology Review program, an initiative of FDA's Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

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