FDA Approves First Therapy for Repigmentation in Vitiligo
July 19, 2022FDA approves Krazati (adagrasib) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation
December 12, 2022November 18, 2022 - Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze ® (asparaginase erwinia chrysanthemi (recombinant)-rywn). Rylaze is approved for use in the U.S. 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.
When first approved in the U.S. in June 2021, under the FDA Real-Time Oncology Review (RTOR) program, the approval had a dosing schedule of 25 mg/m 2 administered IM every 48 hours met the immediate patient need for a non-E.coli-derived asparaginase treatment option while the clinical trial was still ongoing to evaluate additional dosing and administration options.