Amgen leukaemia drug gains breakthrough status
The FDA has given a Breakthrough Therapy Designation to Amgen's new immunotherapy for acute lymphoblastic leukaemia (ALL).
Blinatumomab is the company's lead molecule using the bispecific T cell engager (BiTE) antibody technology, a new approach within immunotherapy, currently one of the most exciting area of oncology drug development.
Amgen acquired blinatumomab and the BiTE technology when it bought German/US oncology-focused Micromet for $1.16 billion in 2012.
The drug is currently in phase 2 trials for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.
BiTE antibodies work by helping to engage the body's immune system to detect and target malignant cells. The modified antibodies help place the T cells within reach of the targeted cancer cell, with the aim of allowing it to trigger cell death (apoptosis).
Amgen is currently investigating BiTE antibodies to treat a wide variety of cancers, and believes it could have a blockbuster franchise on its hands.
The Breakthrough Therapy Designation was based on the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab. Data from the Phase 2 trial were most recently presented at the recent ASCO and European Haematology Association (EHA) meetings
Dr Sean E Harper, executive vice president of Research and Development at Amgen said results from the Phase 2 trial were encouraging and provided a strong basis for a regulatory filing later this year.
ALL is an aggressive cancer of the blood and bone marrow In the US alone, it is estimated that over 6,000 cases were diagnosed in 2013, and in the European Union, more than 7,000 cases are diagnosed each year. In adult patients with relapsed or refractory ALL, median overall survival is just three to five months.