{"id":27252,"date":"2021-07-13T12:33:00","date_gmt":"2021-07-13T12:33:00","guid":{"rendered":"http:\/\/4cbcf0593cde1c9a6cbe2573a5ac6824"},"modified":"2024-11-03T15:14:35","modified_gmt":"2024-11-03T15:14:35","slug":"fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-rywn-for-acute-lymphoblastic-leukaemia-and-lymphoblastic-lymphoma","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-rywn-for-acute-lymphoblastic-leukaemia-and-lymphoblastic-lymphoma\/","title":{"rendered":"FDA Approves Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn for Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma"},"content":{"rendered":"

On 30 June 2021, the US Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients 1 month or older who have developed hypersensitivity to E. coli<\/em>-derived asparaginase.<\/p>\n

Efficacy was evaluated in Study JZP458-201 (NCT04145531), an open-label, multi-cohort, multicentre study in 102 patients with ALL or LBL with hypersensitivity to E. coli<\/em>-derived asparaginase as a component of a multi-agent chemotherapeutic regimen. The median age was 10 years with a range of 1 to 24 years. Patients received Rylaze intramuscularly at various dosages. <\/p>\n

The main efficacy outcome measure was demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U\/mL. The results of modelling and simulations showed that for a dosage of 25 mg\/m2<\/sup> administered intramuscularly every 48 hours, the proportion of patients maintaining NSAA \u2265 0.1 U\/mL at 48 hours after a dose of Rylaze was 93.6% (95% confidence interval 92.6%, 94.6%).<\/p>\n

The most common adverse reactions (incidence > 20%) were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycaemia.<\/p>\n

When replacing a long-acting asparaginase product, the recommended dosage of Rylaze is 25 mg\/m2<\/sup> administered intramuscularly every 48 hours for the required duration of asparaginase activity.<\/p>\n

Full prescribing information for Rylaze is available here<\/a>.<\/p>\n

This review was conducted under Project Orbis<\/a>, an initiative of the FDA Oncology Center of Excellence (OCE)<\/a>. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada.<\/p>\n

This review used the Real-Time Oncology Review<\/a> pilot programme, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment. The FDA approved this application 10 months ahead of the FDA goal date.<\/p>\n

This application was granted fast track and orphan drug designation.<\/p>\n

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE\u2019s Project Facilitate<\/a>.<\/p>\n

Source<\/a><\/p>","protected":false},"excerpt":{"rendered":"

On 30 June 2021, the US Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-27252","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27252","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=27252"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27252\/revisions"}],"predecessor-version":[{"id":45969,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/27252\/revisions\/45969"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=27252"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=27252"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=27252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}