Amgen’s blood cancer drug gets full EU licence
Amgen’s Blincyto has been granted a full European licence in a form of blood cancer following data showing the drug almost doubled overall survival time compared with standard therapy.
The company said the European Commission granted the marketing authorisation based on overall survival data from the phase 3 TOWER study, in adults with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
The drug had previously had a conditional licence in 2015 based on early stage data, which needed renewing each year until the manufacturer could supply mature data.
Blincyto works by helping the body’s immune system target blood cancer, binding to the CD-19 receptor on cancer cells and then engaging with T-cells so that they can attack the disease.
It is a bispecific antibody, with one tip of the “Y”-configured molecule targeting cancer, and the other tip binding to T-cells.
Results of TOWER showed median overall survival with Blincyto was 7.7 months compared with four months for standard chemotherapy.
For patients treated in first salvage, median overall survival was 11.1 months for Blincyto compared with 5.3 months for standard of care.
Safety was comparable to that seen in phase 2 studies in adults.
Approval via the centralised procedure covers all European Union countries, along with Norway, Iceland and Liechtenstein.
The FDA gave full approval in this indication for Blincyto last year, based on data from TOWER and the phase 2 ALCANTARA study.
In the US, Blincyto had been granted accelerated approval based on early data using the FDA’s similar pathway that requires confirmatory data at later date to maintain the licence.
David Reese, senior vice president of Translational Sciences and Oncology at Amgen, said: “Blincyto is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care.”
“For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers.”
“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.”
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