amgen_flag

Amgen’s leukaemia treatment given FDA thumbs up for use in paediatric patients

pharmafile | September 2, 2016 | News story | Medical Communications, Sales and Marketing Amgen, FDA, blincyto, leukaemia 

Amgen has announced that the FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) in the treatment of paediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

The decision is based on results from the drug’s Phase I/II trial and is approved under accelerated approval, with continued approval possibly contingent on its successes in further trials. The open-label, multicentre, single-arm study examined the safety and efficacy of Blincyto in 93 paediatric patients with relapsed or refractory B-cell precursor ALL (second or later bone marrow relapse, any marrow relapse after allogeneic haematopoietic stem cell transplantation [alloHSCT], or refractory to other treatments and had more than 25% blasts in bone marrow).

Blincyto is a bispecific CD19-directed CD3 T cell engager antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.

Advertisement

The drug was granted breakthrough therapy, priority review and orphan drug designations by the FDA and in November 2015 was granted conditional marketing authorisation in the EU.

Matt Fellows

Related Content

MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance

Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …

Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation

Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …

Johnson & Johnson submits robotic surgical system for De Novo classification

Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …

The Gateway to Local Adoption Series

Latest content