Amgen has received approval from the US Food and Drug Administration (FDA) for Blincyto, a drug to treat B-cell precursor acute lymphoblastic leukaemia (ALL) in adults and children.
Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy.
Go deeper with GlobalData
When seeking approval, the company submitted a supplemental biologics licence application (sBLA) for patients in first or second complete remission with minimal residual disease (MRD) of 0.1% or above.
The FDA provided an accelerated approval based on MRD response rate and haematological relapse-free survival (RFS) observed in subjects treated with the drug in the Phase II clinical trial.
The open-label, multi-centre, single-arm trial assessed the safety, efficacy and tolerability of 15mg of Blincyto over four weeks in adults suffering from MRD-positive B-cell precursor ALL in complete hematologic remission following three or more intensive chemotherapy cycles.
Primary endpoint of complete MRD response during the first treatment cycle was met during the trial in 81% of the participants.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataAmgen translational sciences and oncology senior vice-president David Reese said: “Until today, no therapy has been satisfactory in eradicating MRD or approved specifically to treat this high-risk patient population.
“This approval not only supports the use of Blincyto earlier in the ALL treatment continuum, but represents a paradigm shift in the management of ALL.”
The most common adverse reactions observed with Blincyto included pyrexia, infusion-related reactions, headaches, infections, tremors and chills.
Blincyto obtained FDA breakthrough therapy and priority review designations in 2014 and later secured complete approval for the treatment of relapsed or refractory B-ncytcell precursor ALL in adults and children.
