European regulators have expanded the scope of Amgen’s Blincyto to include the treatment of younger patients with a rare type of leukaemia.
The European Commission has approved the drug’s use as monotherapy for the treatment of paediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL), which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
Blincyto (blinatumomab) 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.
The drug first won conditional clearance for use in adults in November 2015, which was converted to full approval in June this year on the back of data from the Phase III TOWER study, in which it showed a superior improvement in median overall over standard of care chemotherapy (7.7 months versus four months, respectively).
Blincyto’s paediatric approval rides on the back of data from the Phase I/II ‘205 study, which showed the drug’s safety and efficacy in this patient group.
“Historically, children with relapsed or refractory ALL have had limited pharmacologic options beyond chemotherapy, resulting in poor outcomes,” said David Reese, executive vice president of R&D at Amgen.
“This approval for Blincyto provides physicians across Europe with an important new immunotherapy option for these young, heavily pretreated patients, delivering on Amgen’s commitment to making a difference in the lives of cancer patients.”