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Jazz oncology drug Rylaze is approved by FDA for treatment of ALL and LBL
Jazz oncology drug Rylaze is approved by FDA for treatment of ALL and LBL. A few days ago, Rylaze, an oncology drug from Jazz Pharmaceuticals, was approved by the US FDA for the treatment of pediatric patients 1 month and older who are allergic to E. coli-derived asparaginase and have developed acute lymphoblastic leukemia (ALL) or lymphoblastic lymph For adult patients with tumors (LBL), the drug is approved as a component of a multi-drug chemotherapy regimen.
Approximately 5,700 patients develop ALL in the United States each year, and about half of them are children. It is estimated that 20% of patients are allergic to standard E. coli-derived asparaginase, and clinical treatment requires substitutes that can be tolerated by the body of this type of patient. According to the FDA, alternative therapies have been lacking in the world for many years. Jazz Pharmaceuticals is the first drug approved by the agency.
The drug can be used in patients with hypersensitivity to E. coli-derived asparaginase, which is an acute lymphoid enzyme. An integral part of the chemotherapy regimen for cellular leukemia (ALL). Rylaze provides a meaningful choice for these patients.
Rylaze was approved based on partial data from the Phase II trial of the Phase II/III study, which evaluated different drug dosing regimens. The phase II study is studying intramuscular administration (IM), and the phase III part will evaluate the efficacy of intravenous drug administration. The FDA Oncology Center of Excellence stated in a press release, “This approval may provide a key component of a potentially curative treatment for children and adult patients with this type of leukemia, bringing a sustainable source of alternatives.”
The drug was designated by the FDA as a rare disease drug for the treatment of ALL/LBL in June 2021. After the drug’s BLA was approved, the drug joined the Real-time Oncology Review (RTOR) program for review, which is an initiative of the FDA’s Center of Excellence in Oncology to provide patients with safe and effective cancer treatments. According to Jazz Pharmaceuticals, the drug is the only recombinant erwinia asparaginase treatment product that can maintain clinically significant levels of asparaginase activity throughout the treatment period. The company expects this new treatment will be available in mid-July.
The drug was evaluated in a trial of 102 patients who were allergic or silently inactivated to E. coli-derived asparaginase. The main indicator of the test is whether the patient has reached and maintained a certain level of asparaginase activity. The study found that after the recommended dose of 25 mg/m² was injected intramuscularly every 48 hours, the target level of asparaginase activity was achieved in 94% of patients.
The most common adverse reactions of the drug include hypersensitivity, pancreatic toxicity, thrombosis, bleeding, and liver toxicity. A retrospective analysis of data from the Pediatric Oncology Group of more than 8,000 patients found that whether these patients are high-risk or standard-risk, slow early responders, due to the drug-related toxicity, the survival results of patients who ultimately did not receive a complete course of treatment Significant reduction occurred.
After approval, Jazz said it will continue to cooperate with the FDA and will submit additional data for the complete patient cohort to evaluate Rylaze intramuscular administration and other administration measures.
(source:internet, reference only)