Jazz Pharmaceuticals Completes FDA Supplemental BLA for Rylaze Monday, Wednesday, Friday Dosing Schedule

The trial studied 3 dosing regimens of asparaginase erwinia chrysanthemi (recombinant)-rywn, with cohort 1a receiving 25 mg/m2administered Monday and Wednesday and 50 mg/m2administered on Friday.

Jazz Pharmaceuticals has completed a supplemental Biologics License Application (sBLA) for the FDA for a Monday/Wednesday/Friday intramuscular dosing schedule for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals) for use 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 aged 1 month and older who have developed hypersensitivity to E.coli-derived asparaginase.

This submission will be reviewed under the FDA Real-Time Oncology Review (RTOR) program and follows asparaginase erwinia chrysanthemi (recombinant)-rywn’s initial approval under the RTOR program in June 2021.

"We were pleased Rylaze, a much-needed therapeutic option, was approved under the RTOR program while the clinical trial was ongoing. Our science-led and patient-focused development program has enabled us to deliver a clinically significant advancement for patients," said Rob Iannone, MD, MSCE, executive vice president, global head of research and development of Jazz Pharmaceuticals, in a press release. "With a dosing schedule of Rylaze administered 25/25/50 mg/m2 on Monday/Wednesday/Friday, patients maintain a clinically meaningful level of nadir serum asparaginase activity through the entire duration of treatment. We look forward to submitting two additional regulatory applications this year to ensure as many patients as possible can have access to a reliable and high-quality supply of this important therapy, including another regulatory application to FDA to support the intravenous route of administration and an additional application in Europe later this year."

The sBLA is supported by data from the 3-cohort intramuscular administration part of the phase 2/3 trial of asparaginase erwinia chrysanthemi (recombinant)-rywn in adult and pediatric patients with ALL and LBL who have developed hypersensitivity to an E.coli-derived asparaginase. The trial studied 3 dosing regimens of asparaginase erwinia chrysanthemi (recombinant)-rywn, with cohort 1a receiving 25 mg/m2administered Monday and Wednesday and 50 mg/m2administered on Friday.

The initial results showed that in cohort 1c, a dosing regimen of asparaginase erwinia chrysanthemi (recombinant)-rywn administered 25 mg/m2 on Monday and Wednesday and 50 mg/m2administered on Friday demonstrated a positive benefit-to-risk profile, showing that asparaginase erwinia chrysanthemi (recombinant)-rywn maintains a clinically meaningful level of nadir serum asparaginase activity ≥0.1 IU/mL at both 48 and 72 hours. Additionally, the safety profile was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy.

REFERENCE

Jazz Pharmaceuticals completes U.S. FDA Supplemental Biologics License Application for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday dosing schedule. Jazz Pharmaceuticals. February 2, 2022. Accessed February 2, 2022. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-completes-us-fda-supplemental-biologics