CHMP recommends Blincyto (blinatumomab) for conditional marketing approval to treat Ph-relapsed or refractory B-precursor ALL- Amgen

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinion recommending conditional marketing authorisation for Blincyto (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). A 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. Blincyto is the first clinical validation of the bispecific T cell engager (BiTE) platform, an innovative approach that can help the body's own immune system fight cancer.

The blinatumomab conditional marketing authorisation is based on results of the '211 and '206 trials. In the '211 study: 42.9% of evaluable patients receiving blinatumomab achieved complete remission or complete remission with partial haematological recovery (CR/CRh). 17% of patients underwent allogeneic haematopoietic stem cell transplantation (HSCT) in CR/CRh induced with blinatumomab. 82.2% of those who achieved CR/CRh achieved deep molecular remission, or minimal residual disease (MRD) response, a measure of eradication of residual disease at the molecular level. The most serious adverse reactions included: infections (31.7%), neurologic events (16.4%), neutropenia/febrile neutropenia (15.3%), cytokine release syndrome (0.5%) and tumour lysis syndrome (0.5%).