FDA grants breakthrough therapy status for Celator’s VYXEOS to treat AML
Oncology-focused, biopharmaceutical company Celator Pharmaceuticals has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its VYXEOS, also known as CPX-351.
Oncology-focused, biopharmaceutical company Celator Pharmaceuticals has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its VYXEOS, also known as CPX-351.
VYXEOS serves as an investigational product in development that can be used to treat patients affected with acute myeloid leukemia (AML) and other types of blood cancers.
FDA has granted the designation mainly based on the successful results attained from the Phase III clinical trial of the product administered on older patients with previously untreated high-risk (secondary) AML.
Under the trial, the product could effectively treat adults affected with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Celator Pharmaceuticals CEO Scott Jackson said: "We are very happy the FDA granted Breakthrough Therapy designation for VYXEOS.
"We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible."
"The breadth of the designation includes all adults with t-AML and AML-MRC and is encouraging since AML patients are in need of advancements in treatment.
"We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible."
In the trial, the median overall survival for patients treated with VYXEOS was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favour of VYXEOS.
Later this year, Celator intends to submit a new drug application (NDA) to the FDA.
Image: Bone marrow aspirate demonstrating acute myeloid leukemia. Photo: courtesy of VashiDonsk / Wikipedia.