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January 3, 2019

FDA approves Bristol-Myers’ Sprycel to treat children with Ph+ ALL

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Sprycel (dasatinib) drug for children with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL).

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Sprycel (dasatinib) drug for children with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL).

The authorisation allows the use of Sprycel in combination with chemotherapy and covers paediatric patients aged one year or older and newly diagnosed.

Sprycel is a second-generation tyrosine kinase inhibitor, and holds approval for the treatment of Ph+ chronic myeloid leukaemia (CML) in chronic phase in children one year of age and above.

Bristol-Myers Squibb haematology development lead Jeffrey Jackson said: “We recognise the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to paediatric oncology.

“Building on our previous indication for children with Ph+ chronic myeloid leukaemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of paediatric leukaemia.”

“Building on our previous indication for children with Ph+ chronic myeloid leukaemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of paediatric leukaemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”

For the latest approval, the FDA reviewed results from the multi-centre, single-arm Phase II CA180-372 clinical trial performed in 78 newly diagnosed paediatric patients suffering from B-cell precursor Ph+ ALL.

The combination of Sprycel tablets with chemotherapy showed 64.1% event-free survival (EFS) binary rate at three years.

During safety analysis in 81 patients, fatal adverse reactions were observed in three participants, while eight had adverse reactions, including fungal sepsis, thrombocytopenia and CMV infection, which led to treatment discontinuation.

The most common serious adverse reactions in the trial were pyrexia, mucositis, febrile neutropenia, diarrhoea, sepsis, hypotension, infections, hypersensitivity, vomiting, renal insufficiency, abdominal pain and musculoskeletal pain.

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