FDA News

FDA approves Lumoxiti for pretreated hairy cell leukemia

Richard Pazdur, MD
Richard Pazdur

The FDA approved moxetumomab pasudotox-tdfk injection for the treatment of adults with relapsed/refractory hairy cell leukemia who have received at least two prior system therapies.

Moxetumomab pasudotox-tdfk (Lumoxiti, MedImmune/AstraZeneca) is a CD22-directed cytotoxin, the first of this type of treatment for hairy cell leukemia.

The FDA based this approval on a single-arm, open-label trial of 80 patients with relapsed/refractory hairy cell leukemia who received at least two prior systemic therapies, including a purine nucleoside analog.

As HemOnc Today previously reported, researchers presented the results of this trial at ASCO Annual Meeting.

Results showed 30% of patients achieved a durable complete response, defined as the maintenance of hematologic remission for more than 180 days after complete response.

The overall response rate was 75%.

“Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”

The most common side effects associated with moxetumomab pasudotox-tdfk included infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia and diarrhea.

The prescribing information for this therapy includes a boxed warning about the risk for developing capillary leak syndrome and hemolytic uremic syndrome.

The FDA granted the moxetumomab pasudotox-tdfk application fast track, priority review and orphan drug designations.

 

 

Richard Pazdur, MD
Richard Pazdur

The FDA approved moxetumomab pasudotox-tdfk injection for the treatment of adults with relapsed/refractory hairy cell leukemia who have received at least two prior system therapies.

Moxetumomab pasudotox-tdfk (Lumoxiti, MedImmune/AstraZeneca) is a CD22-directed cytotoxin, the first of this type of treatment for hairy cell leukemia.

The FDA based this approval on a single-arm, open-label trial of 80 patients with relapsed/refractory hairy cell leukemia who received at least two prior systemic therapies, including a purine nucleoside analog.

As HemOnc Today previously reported, researchers presented the results of this trial at ASCO Annual Meeting.

Results showed 30% of patients achieved a durable complete response, defined as the maintenance of hematologic remission for more than 180 days after complete response.

The overall response rate was 75%.

“Lumoxiti fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This therapy is the result of important research conducted by the National Cancer Institute that led to the development and clinical trials of this new type of treatment for patients with this rare blood cancer.”

The most common side effects associated with moxetumomab pasudotox-tdfk included infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia and diarrhea.

The prescribing information for this therapy includes a boxed warning about the risk for developing capillary leak syndrome and hemolytic uremic syndrome.

The FDA granted the moxetumomab pasudotox-tdfk application fast track, priority review and orphan drug designations.

 

 

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