FDA breakthrough for Amgen
pharmafile | July 2, 2014 | News story | Research and Development, Sales and Marketing | Amgen, BiTE antibody blinatumomab, FDA, all, leukaemia
Amgen has taken a major step down the road to getting its investigational cancer drug blinatumomab onto the market after the US regulator granted it breakthrough therapy designation.
The bispecific T cell engager (BiTE) antibody is being looked at in adults with Philadelphia-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL), which is a particularly aggressive form of the disease.
“There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options,” says Sean Harper, executive vice president of R&D at Amgen.
ALL accounts for more than 12% of leukaemia, with 31,000 people – out of 42,000 diagnosed with the disease each year – expected to die from it. In adults with relapsed or refractory ALL, median overall survival is only three to five months.
In the US, 6,000 cases of ALL were diagnosed in 2013, and around 7,000 in the European Union each year.
“The results from the Phase II trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease,” Harper adds.
Blinatumomab came to Amgen as part of the company’s $1.16 billion acquisition of German biotech firm Micromet in January 2012.
Results from the Phase II trial on which the Food and Drug Administration based its breakthrough decision were recently presented at ASCO, and involved 189 patients treated with blinatumomab.
The drug is designed to direct the body’s cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukaemias and lymphomas.
ALL affects the blood and bone marrow, progresses rapidly and affects immature blood cells, rather than mature ones.
Blinatumomab has also been in development for the treatment of non-Hodgkin’s lymphoma (NHL), and Amgen believes it could have applications in other blood cancers.
Adam Hill
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