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FDA grants Vyxeos® (CPX-351) approval for the treatment of t-AML and AML-MRC patients
On 3rd August 2017, the U.S. Food and Drug Administration (FDA) granted approval to Vyxeos® (CPX-351) liposome injection for the treatment of adult patients with newly diagnosed Therapy-related Acute Myeloid Leukemia (t-AML) or newly diagnosed AML with Myelodysplasia-Related Changes (AML-MRC).1 This approval comes after the New Drug Application submitted for Vyxeos® in April 2017 and the priority review designation granted to Vyxeos® in May 2017, which was reported here.
The FDA approval granted for Vyxeos® (a liposomal formulation of daunorubicin plus cytarabine co-encapsulated at a molar ratio of 1:5) was based on clinical data from the pivotal phase III study (NCT01696084), which evaluated the safety and efficacy of Vyxeos® compared to cytarabine and daunorubicin (7+3) in patients with newly diagnosed t-AML and AML-MRC.
In total, 309 newly diagnosed t-AML and AML-MRC patients (60–75 years) were randomized to receive either Vyxeos® (n = 153) or 7+3 (cytarabine and daunorubicin, n = 156) induction therapy. The endpoints of the study were Overall Survival (OS), Event Free Survival (EFS), and Complete Remission plus Complete Remission with Incomplete blood count recovery (CR+CRi). 2
The key results of the study were:
- Median OS in patients receiving Vyxeos® and 7+3; 9.56 vs 5.95 months, HR = 0.69, P = 0.005
- EFS was superior in patients receiving Vyxeos® compared to 7+3; HR = 0.74, P = 0.021
- CR+CRi response in patients receiving Vyxeos® and 7+3; 47.7% vs 33.3%, P = 0.016
Prof. Jeffrey Lancet, Lee Moffitt Cancer Center & Research Institute, Florida, USA, one of the investigators of this pivotal phase III study highlighted in an interview with AGP that the “very difficult to treat subgroup of patients with t-AML” seemed to “benefit proportionally from CPX-351 compared to 7+3” which he said was “gratifying”.
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