register

News & Trends - Pharmaceuticals

BMS’ second-generation TKI now registered to treat children with Ph+ leukaemia

Health Industry Hub | July 6, 2020 |

Pharma News: Coping with a paediatric cancer diagnosis, including identifying the right treatment regimen, can take a significant physical and emotional toll on children and their families.

The Therapeutic Goods Administration (TGA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of paediatric patients newly diagnosed with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. 

Sprycel is the only second-generation tyrosine kinase inhibitor (TKI) approved for this patient population. 

The efficacy of Sprycel tablets in combination with chemotherapy was evaluated in a single cohort of the Phase 2, multicentre, single-arm CA180-372 study, which included paediatric patients with newly diagnosed B-cell precursor Ph+ ALL. At three years, the study demonstrated an event-free survival (EFS) binary rate of 64.1% (95% confidence interval [CI]: 52.4 to 74.7).

Acute lymphoblastic leukaemia is characterised by chromosomal abnormalities and genetic alterations involved in the differentiation and proliferation of lymphoid precursor cells. The most common childhood cancer, ALL represents 20% of all cancers diagnosed in persons aged less than 20 years, or more than 3,000 new cases each year. Only 3% of children who have ALL have the Ph+ subtype, which means they have a chromosome alteration that results in a specific mutation of the BCR-ABL gene.

In addition to this paediatric approval, Sprycel is approved for use in children with Ph+ chronic myeloid leukaemia (CML) in chronic phase (CP).


News & Trends - Pharmaceuticals

Clinical and Laboratory Haematologist and Lead of the Molecular Haematology Service

Clinicians call for closer monitoring of patients post CAR T therapy

Health Industry Hub | February 17, 2025 |

Australian clinicians are raising questions about whether cancer patients need closer monitoring after receiving CAR T-cell therapy. A Peter MacCallum […]

More


News & Trends - MedTech & Diagnostics

Next-gen surgical mesh to fill critical gap after ban

Next-gen surgical mesh to fill critical gap after regulatory ban

Health Industry Hub | February 17, 2025 |

Next-generation urogynaecological surgical mesh implants are on the horizon for women suffering from pelvic organ prolapse (POP). This development aims […]

More


News & Trends - Pharmaceuticals

Contraceptive lawsuit against Bayer fails

Contraceptive lawsuit against Bayer fails

Health Industry Hub | February 17, 2025 |

The Victorian Supreme Court has dismissed a class action against Bayer for an allegedly defective contraceptive device. Justice Andrew Keogh […]

More


News & Trends - Pharmaceuticals

NSW Government ignored warnings since 2018: Mental health system unravels as psychiatrists quit en masse

NSW Government ignored warnings since 2018: Mental health system unravels as psychiatrists quit en masse

Health Industry Hub | February 17, 2025 |

The New South Wales Labor government’s plan to “redesign” the state’s mental health system, while excluding psychiatrists, has sparked intense […]

More


This content is copyright protected. Please subscribe to gain access.