FDA Approves New Type of Treatment for Hairy Cell Leukemia
The FDA approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) for treating adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including purine nucleoside analog treatment.
Approved under a priority review, Lumoxiti is the first med greenlighted by the FDA for the rare blood cancer HCL in over 20 years.
The treatment is not recommended for patients with severe renal impairment.
The drug “represents a promising non-chemotherapeutic agent for HCL, addressing an unmet medical need,” said Robert Kreitman, principal investigator for the drug’s Phase III trial.