FDA green light for new kind of treatment for hairy cell leukemia

Approval of the immunotoxin Lumoxiti (moxetumomab pasudotox-tdfk), a first-in-class medicine for hairy cell leukemia, marks first new treatment option for patients in over 20 years

AstraZeneca (LSE: AZN) and MedImmune, its global biologics R&D arm, late yesterday announced that the US Food and Drug Administration has approved Lumoxititfor the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analogue. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). The Phase III trial results demonstrated 75% (95% confidence interval [CI]: 64, 84) of patients receiving the drug achieved an overall response; 30% (95% CI: 20, 41) had a durable complete response.

The Anglo-Swedish pharma major’s chief executive Pascal Soriot has previously assessed this drug having a potential peak sales figure of up to $1 billion. Jefferies analysts have a more achievable $500 million peak sales projection, and is another boost for its oncology portfolio..