European regulators have awarded Amgen’s Blincyto full approval for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow thought to affect around 900 patients a year in the region.
Blincyto (blinatumomab) initially won conditional approval for this indication in November 2015, on the back of data from Phase II trials, in one of which 42.9 percent of patients achieved complete remission (CR) or CR with partial haematological recovery when treated with the drug.
The conversion to full authorisation rides on the back of data from the Phase III TOWER study, in which Blincyto showed a superior improvement in median OS over standard of care (SOC) chemotherapy (7.7 months versus four months, respectively).
"Blincyto is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care," said David Reese, senior vice president of Translational Sciences and Oncology at Amgen.
"The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces Blincyto as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer."
Blincyto is an example of a BiTE antibody construct, a type of immunotherapy designed to help the body’s immune system to detect and target malignant cells. The modified antibodies engage two different targets simultaneously, thereby juxtaposing killer T cells to cancer cells to trigger apoptosis.