US regulators have agreed to undertake a speedy review of Amgen's cancer immunotherapy Blincyto for use in younger patients with a rare form leukaemia.
The US Food and Drug Administration will consider whether Blincyto (blinatumomab) can be used to treat paediatric and adolescent patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) within a six-month window.
ALL is a rare and rapidly progressing cancer of the blood and bone marrow, and is the most common type of cancer in children. Of around 2,500 US children and adolescents diagnosed with B-cell precursor ALL each year, 15-20 percent will experience relapse or fail to achieve remission, highlighting the need for new treatment options.
Blincyto was won conditional approval in the US back in 2014 for Ph- precursor B-cell acute lymphoblastic leukaemia; the application to expand its treatment scope is based on data from a Phase I/II trial in paediatric patients with relapsed or refractory forms of the disease, which met its primary endpoint of complete remission within the first two cycles of treatment.
"Children and adolescents with ALL who experience a second or greater relapse or are refractory often have a dismal prognosis with survival rates below 10 percent," said Sean Harper, executive vice president of Research and Development at Amgen. "The FDA's acceptance of the sBLA submission for Blincyto reinforces immunotherapy as a potential option for children in need of new treatments to fight this complex disease and help prevent further relapse."