Rylaze was granted Fast Track Designation by the FDA in October 2019 for acute lymphoblastic leukemia and was approved as part of the Real-Time Oncology Review program.
The National Comprehensive Cancer Network (NCCN) has added the newly approved asparaginase erwinia chrysanthemia (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals) to its guidelines for pediatric and adult patients with acute lymphoblastic leukemia (ALL).
Rylaze is included as a treatment option for individuals with hypersensitivity to E. coli asparaginase products as a component of multi-agent chemotherapeutic regimens needed to complete the full treatment course, according to a press release. It was approved by the FDA on June 30, 2021, for use a component of chemotherapeutic regimens given by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LB) in adults and children with hypersensitivity to E. coli-derived asparaginase.
“Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from E. coli are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients,” said Rob Iannone, MD, MSCE, executive vice president of research and development and chief medical officer at Jazz Pharmaceuticals, in a press release.
Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform, according to the press release. It was granted Fast Track Designation by the FDA in October 2019 for ALL and was approved as part of the Real-Time Oncology Review program.
NCCN Guidelines are vital tools for oncology experts, including physicians, nurses, pharmacists, payers, and patients. The guidelines present expert recommendations for cancer screenings, diagnoses, and treatments, as well as treatment options that can increase patients’ chances of favorable outcomes.
“Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence,” Iannone said in the press release. “We are pleased by the NCCN’s decision to quickly incorporate Rylaze into the Clinical Practice Guidelines for ALL.”
National Comprehensive Cancer Network Adds Newly Approved Rylaze to Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia. News release. Jazz Pharmaceuticals; July 22, 2021. Accessed August 23, 2021. https://investor.jazzpharma.com/news-releases/news-release-details/national-comprehensive-cancer-networkr-adds-newly-approved