On July 13, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will host a webcast on Tuesday, July 20, 2021 at 4:30 p.m. ET / 9:30 p.m. IST to provide an update on Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), which was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 (Press release, Jazz Pharmaceuticals, JUL 13, 2021, View Source [SID1234584827]).
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Jazz senior management will be joined by Dr. Luke Maese, associate professor of pediatrics, University of Utah – Huntsman Cancer Institute, Primary Children’s Hospital, to discuss the Rylaze FDA approval, commercial launch and an overview of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) and the need for recombinant, non-E. coli derived asparaginase treatments.
About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.
The full U.S. Prescribing Information for Rylaze is available at: <View Source>
Important Safety Information
RYLAZE should not be given to people who have had:
Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:
Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.
Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.
RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.