US regulators wave through Pfizer’s leukaemia drug

August 18, 2017  22:36

The U.S. Food and Drug Administration (FDA) said on Thursday it approved Pfizer Inc's rare blood cancer drug, Besponsa, with a boxed warning.

Besponsa was approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Based on the typical duration of treatment, the total cost of the drug will be $168,300, before discounts to purchasers, Pfizer told Reuters.

Besponsa will carry a boxed warning, the severest form of warning by the FDA, saying patients treated with the drug were at a risk of severe liver damage as well as an increased risk of death for patients who take the drug after receiving a certain type of stem cell transplant.

B-cell precursor ALL is a rapidly progressing cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell.

Besposa — approved in the European Union earlier this year — is a targeted therapy that binds to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancer cells.

 

 

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