Multi-center study led by Dana-Farber/Boston Children's contributes to FDA approval of a new treatment for acute lymphoblastic leukemia
February 04, 2019
Dana-Farber/Boston Children's Cancer and Blood Disorders Center announced today that data generated from its acute lymphoblastic leukemia (ALL) Consortium clinical trial was a critical factor leading to the approval of a new treatment for acute lymphoblastic leukemia. The U.S. Food and Drug Administration (FDA) recently approved Servier Pharmaceuticals' ASPARLASTM (calaspargase pegol-mknl) as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL in pediatric and young adult patients age 1 month to 21 years.
"We are very proud that the clinical trial played an important role in the approval of a new drug for childhood leukemia," said Lewis B. Silverman, MD, Director of Clinical Research and Clinical Care at Dana-Farber/Boston Children's and the trial's Principal Investigator.
ASPARLAS is a novel asparaginase which was approved based on the results of two trials, including the DFCI ALL Consortium Protocol 11-001, a multi-center randomized clinical trial of standard backbone chemotherapy, along with either ASPARLAS or pegaspargase. As ASPARLAS has a longer half-life than pegaspargase, it was administered every three weeks rather than every two. The trial demonstrated that ASPARLAS was associated with similar drug activity levels and safety profile as pegaspargase. Importantly, there were no differences between the two drugs in measures of leukemia response.
ASPARLAS will be available later in 2019.
ASPARLASTM (calaspargase pegol-mknl) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.
Important Safety Information
- History of serious hypersensitivity reactions to pegylated L asparaginase
- History of serious thrombosis during L asparaginase therapy
- History of serious pancreatitis related to previous L asparaginase treatment
- History of serious hemorrhagic events during previous L asparaginase therapy
- Severe hepatic impairment
WARNINGS and PRECAUTIONS
Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.
Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis.
Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.
Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.
Hepatotoxicity: Hepatotoxicity and abnormal liver function, including elevations of transaminase, bilirubin (direct and indirect), reduced serum albumin, and plasma can occur. Evaluate bilirubin and transaminases at least weekly during cycles of treatment that include ASPARLAS through at least 6 weeks after the last dose of ASPARLAS. In the event of serious liver toxicity, discontinue treatment with ASPARLAS and provide supportive care.
The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial are elevated transaminase, bilirubin increased, pancreatitis and abnormal clotting studies.
For more information, please refer to the full prescribing information: www.accessdata.fda.gov/drugsatfda_docs/label/2018/761102s000lbl.pdf