BRIEF—FDA approves new regimen for Jazz' Rylaze

The US Food and Drug Administration yesterday approved a new Monday-Wednesday-Friday dosing regimen for Jazz Pharmaceuticals' Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), with the news edging the drugmaker’s shares up 1.4% to $147.18.

Under the new regimen, patients should receive 25mg/m2 intramuscularly on Monday and Wednesday mornings, and 50mg/m2 intramuscularly on Friday afternoon.

It also is approved to be administered every 48 hours at a dose of 25mg/m2 intramuscularly.

Rylaze was first approved in the USA in June 2021 under the FDA Real-Time Oncology Review (RTOR) program.

The drug is approved for use in the USA as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.

Rylaze net product sales were $73.5 million in third-quarter 2022.