Amgen gets US FDA full approval for Blincyto to treat minimal residual disease-positive b-cell precursor ALL

Amgen announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for the treatment of adults and paediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two phase 3 studies that were submitted. The approval converts Blincyto's accelerated approval to a full approval. "We are pleased the FDA has granted full approval for Blincyto, the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy and the first to be FDA-approved for MRD in 2018," said David M. Reese, M.D., executive vice president of research and development at Amgen. "Today's full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients." Amgen continues to advance a robust development program for Blincyto, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients. "In a phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response," said principal investigator Elias Jabbour, M.D., Department of Leukaemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston. "The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population." Blincyto is a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers. Blincyto was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the US for the treatment of: CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and paediatric patients; relapsed or refractory CD19-positive B-cell precursor ALL in adults and paediatric patients. In the European Union (EU), Blincyto is indicated as monotherapy for the treatment of: adults with Philadelphia chromosome-negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL); adults with Philadelphia chromosome-negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%; paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation. Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving Blincyto. Interrupt or discontinue Blincyto and treat with corticosteroids as recommended. Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving Blincyto. Interrupt or discontinue Blincyto as recommended. BiTE (bispecific T-cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumour-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumour types through tumour-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumours, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.

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