Jazz Pharma (JAZZ) Gets FDA Approval for Leukemia Drug Rylaze
Zacks Investment Research | Jun 30, 2021 10:00PM ET
Jazz Pharmaceuticals (NASDAQ:JAZZ) plc industry 's decrease of 8.7%.
The BLA included data from three IM cohorts of the ongoing pivotal phase II/III study that demonstrated that treatment with Rylaze maintained a clinically meaningful level of asparaginase activity throughout the entire duration of treatment.
Jazz has a strong oncology portfolio with several hematology/oncology drugs in its portfolio, aiding growth and diversification. The company is developing a few oncology candidates and is also focused on expanding the labels of marketed drugs — Defitelio and Vyxeos. Moreover, approval to Rylaze will help to partially offset loss of sales of Erwinaze, which was approved for a similar indication. Jazz expects to be able to sell Erwinaze only in the first half of 2021, following expiry license and supply agreement with Porton Biopharma Limited last year.
In March 2021, the FDA approved Vyxeos label expansion to include pediatric AML patients. Meanwhile, Jazz is also evaluating Vyxeos in other AML patient populations, such as adults with standard or intermediate risk AML, in combination with targeted AML treatments and in new populations (myelodysplastic syndromes, or MDS). Last year, Jazz added a new drug to its oncology portfolio with FDA approval to Zepzelca for treating relapsed small cell lung cancer.
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