New treatment for acute lymphoblastic leukemia approved in EU
New treatment for acute lymphoblastic leukemia approved in EU
24 Nov 2015The European Commission (EC) has granted conditional marketing authorization* for blinatumomab (marketed as Blincyto) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
Treating a rare and rapidly progressing cancer
Acute lymphoblastic leukemia is a rare and rapidly progressing cancer of the blood and bone marrow. For adults with relapsed or refractory acute lymphoblastic leukemia, the median overall survival is just three to five months. It is estimated that the incidence of adults with Ph-relapsed or refractory B-precursor acute lymphoblastic leukemia in the European Union is approximately 900 patients per year.
Blincyto [blinatumomab] is the first clinical validation of the BiTE platform, a new and innovative approach that helps the body’s own immune system fight cancer.
Adverse events of the treatment
The conditional marketing authorization for blinatumomab is based on results of two Phase 2 studies, study ‘211 and ‘206. In the ‘211 trial, 42.9% of patients achieved complete remission (CR) or CR with partial hematological recovery (CRh) with single-agent blinatumomab.
The most serious adverse reactions that occurred during blinatumomab treatment in the pivotal ‘211 trial included infections, neurologic events, neutropenia/febrile neutropenia, cytokine release syndrome and tumor lysis syndrome.
Where will the drug be available?
“This is the first major advance in more than two decades for patients with this hard-to-treat cancer” said Max S. Topp, M.D., professor, Hospital of Wuerzburg, Germany.
Approval from the European Commission grants a centralized conditional marketing authorization with unified labelling in the 28 countries that are members of the European Union. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the European Commission.
Blinatumomab was granted orphan drug designation by the European Medicines Agency in 2009 for the treatment of acute lymphoblastic leukemia.
*Conditional license requires the license to be renewed every year and it will be converted to full standard license once post-licensing commitments have been fulfilled.
Source: eCancer News