Benzinga | Jul 22, 2021 04:16PM EDT

Jazz Pharma Reports National Comprehensive Cancer Network Adds Co.'s Newly-Approved Rylaze To Clinical Practice Guidelines In Oncology For Acute Lymphoblastic Leukemia

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the National Comprehensive Cancer Network(r) (NCCN) added Rylaze(tm) (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines(r)) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients.

The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric ALL now include asparaginase erwinia chrysanthemi (recombinant)-rywn as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen to complete the full treatment course.

"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, M.D., M.S.C.E., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "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. We are pleased by the NCCN's decision to quickly incorporate Rylaze into the Clinical Practice Guidelines for ALL."

Rylaze was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 for use as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.1 The approval followed review of a Biologics Licensing Application under the FDA's Real-Time Oncology Review program, and it was based on clinical data from a pivotal Phase 2/3 trial conducted in collaboration with the Children's Oncology Group.

The NCCN Guidelines play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options that may increase the chances of favorable outcomes for patients.

The NCCN is a not-for-profit alliance of 30 leading U.S. cancer centers devoted to patient care, research and education that aims to facilitate quality, effective, efficient and accessible care so that patients can live better lives.