Erytech Pharma has submitted a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Graspa/Ery-Asp (human erythrocytes...
Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted marketing authorization for Enrylaze (JZP 458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to...
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of...
Jazz Pharmaceuticals announced the FDA approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase.
The FDA on 18 November 2011 has approved Erwinase from EUSA Pharma as a component of a multi-agent chemotherapeutic regimen...
Jazz Pharmaceuticals plc announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization of JZP 458(Enrylaze) (a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
Jazz Pharmaceuticals plc announced that the company has initiated the submission of a Biologics License Application (BLA)
A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase).
Erytech reports positive Phase III results from its pivotal study with Graspa (human erythrocytes encapsulating L-asparaginase) in Acute Lymphoblastic Leukemia....