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FDA approves Vyxeos for poor-prognosis acute myeloid leukemia
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The FDA approved CPX-351 for two types of poor-prognosis acute myeloid leukemia.
CPX-351 (Vyxeos, Jazz Pharmaceuticals) — a liposome-encapsulated combination of daunorubicin and cytarabine — is indicated for patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
“Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, said in a company-issued press release. “The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community.”
The FDA based the approval on data from the randomized phase 3 CLTR0310-301 trial, designed to compare CPX-351 with a standard combination of cytarabine and daunorubicin (7+3) for 309 patients aged 60 to 75 years with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
OS served as the primary endpoint.
Patients who received CPX-351 achieved significantly longer median OS (9.6 months vs. 5.9 months; HR = 0.69; 95% CI, 0.52-0.9). The complete response rate also was significantly higher in the CPX-351 group (38% vs. 26%; P = .036).
Researchers reported all-cause 30-day mortality rates of 6% in the CPX-351 group and 11% in the control group.
A higher percentage of patients assigned CPX-351 underwent hematopoietic stem cell transplant (34% vs. 25%).
“Vyxeos is the first chemotherapy to demonstrate an OS advantage over the standard of care in a phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes,” Jeffrey E. Lancet, MD, chair of the department of malignant hematology at Moffitt Cancer Center, said in the release. “The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance.”
The most common adverse reactions associated with CPX-351 included hemorrhage events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders and vomiting.