The U.S. Food and Drug Administration has accepted Jazz Pharmaceuticals’ New Drug Application (NDA) for Vyxeos, an injected formulation of cytarabine and daunorubicin as a treatment for acute myeloid leukemia, or AML.
The injected version increased the survival of patients treated with a standard IV administration of the drugs, according to a Phase 3 clinical trial that Vyxeos conducted.
Jazz said the FDA will consider the New Drug Application under its Priority Review Scheme, which is aimed at speeding approvals of therapies that meet unmet needs.
“We are pleased by the FDA’s acceptance of the NDA filing with Priority Review, as this action emphasizes the need for new treatments for patients living with AML,” Dr. Karen Smith, Jazz’s chief medical officer, said in a press release.
The company included data from five clinical trials in its application. One was a Phase 3 trial (NCT01696084) of Vyxeos in high-risk AML patients. The trial, sponsored by the Leukemia and Lymphoma Society, returned positive findings last year.
Vyxeos is composed of the drugs cytarabine and daunorubicin encased in nano-sized membrane-bound bubbles. In the Phase 3 study, researchers compared the effectiveness of Vyxeos injections with standard IV administration of the two drugs. The IV approach is often referred to as 7+3 because it involves three days’ administration of daunorubicin and seven days of cytarabine.
Jazz announced at the American Society of Clinical Oncology 2016 annual meeting in Chicago that the study had met its primary goal of Vyxeos increasing the survival time of AML patients, compared with 7+3.
Patients who received Vyxeos lived 9.56 months after treatment, more than three months longer than the 5.95 months of patients treated with 7+3.
A year after the trial started, 41.5 percent of the Vyxeos group were still alive, versus only 27.6 percent of the 7+3 group. After another year, the figures were 31.1 percent and 12.3 percent.
Response rates were also better in the Vyxeos group, while moderate and serious adverse events were similar.
“We look forward to working with the FDA during this review process to obtain approval of Vyxeos as quickly as possible, as AML is the most common of all adult leukemias and AML patients have among the lowest survival rates,” Smith said.
Limited treatments exist for AML, a disease with a poor prognosis. Study results showing that Vyxeos can increase patients’ survival is what prompted the FDA to grant the drug Breakthrough Therapy Designation in 2016.
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