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Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients
By: News Feed | Last updated: 23rd November 2018 | In: Chemotherapy, Haematology, Targeted Therapies, US FDA Onc\Haem Approvals
AML, cytarabine, Daurismo, FDA, glasdegib, LDAC, leukaemia, Pfizer, Sonic hedgehog
On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer), a Sonic hedgehog inhibitor, in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.
BRIGHT AML 1003
The multicentre, open-label, BRIGHT AML 1003 study (NCT01546038) randomised 115 newly-diagnosed AML patients in a 2:1 fashion to receive either glasdegib plus LDAC (N=77) or LDAC alone (N=38) until disease progression or unacceptable toxicity. Patients had to meet at least one of the following criteria:
- Age 75 years or older;
- Severe cardiac disease;
- Baseline Eastern Cooperative Oncology Group (ECOG) performance status of 2;
- Baseline serum creatinine >1.3 mg/dL.
The primary efficacy measure included the improvement in overall survival (OS) calculated from the date of randomisation to the date of death due to any cause.
At a median follow-up of 20 months, the median OS was 8.3 months (95% CI, 4.4-12.2) for glasdegib plus LDAC and 4.3 months (95% CI, 1.9-5.7) with LDAC alone (HR=0.46; 95% CI, 0.30-0.71; P=0.0002).
Common adverse reactions in ≥ 20% of patients included anaemia, fatigue, haemorrhage, febrile neutropenia, musculoskeletal pain, nausea, oedema, thrombocytopenia, dyspnoea, decreased appetite, dysgeusia, mucositis, constipation, and rash.
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