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Home Industry News FDA approves AbbVie’s chronic lymphocytic leukemia treatment

FDA approves AbbVie’s chronic lymphocytic leukemia treatment

7th March 2016

A proposed treatment for chronic lymphocytic leukemia developed by AbbView has been approved by regulators in the US.

The US Food and Drug Administration has backed Imbruvica as a first-line treatment for the condition, following positive results in Phase 3 trials.

The tests evaluated its use against chlorambucil in 269 treatment-naïve patients aged 65 or over, all of whom had chronic lymphocytic leukemia or small lymphocytic lymphoma.

Dr Jan Burger of the University of Texas, one of the scientists involved in the clinical trials, stated that the progression-free survival data seen in previously untreated chronic lymphocytic leukemia was "strong and encouraging".

Michael Severino of AbbVie commented: "This approval represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy."

He added that AbbVie is committed to significantly improving the lives of patients with haematologic malignancies and will continue exploring ways to improve treatment options.ADNFCR-8000103-ID-801814108-ADNFCR

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